MAUDE: Analysis of Robotic-Assisted Gynecologic Surgery

Manoucheri, E.; Weizman, Noga Fuchs; Cohen, Sarah L.; Wang, Karen C.; Einarsson, Jon I.

doi:10.1016/j.jmig.2013.12.122

Cited by 27 publications

(21 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It is also important to stress that such concerns about robotic methods are based on a small number of scientific analyses and are greatly influenced by negative feedback from the US Food and Drug Administration (FDA) and the MAUDE (Manufacturer and User Facility Device Experience) database. These are largely concerned with the functioning of da VINCI in different surgical specialties and are not backed up by sufficient data [ 64 – 67 ]. In contrast, over 700 successful donor nephrectomies have been performed to date as well as more than 70 renal transplants, which have contributed to a reduced number of infections and other side risk factors correlated with standard open renal replacement.…”

Section: The Development Of Surgical Methodsmentioning

confidence: 99%

Novel surgical techniques, regenerative medicine, tissue engineering and innovative immunosuppression in kidney transplantation

Nowacki¹,

Nazarewski²,

Kloskowski³

et al. 2016

aoms

View full text Add to dashboard Cite

On the 60th anniversary of the first successfully performed renal transplantation, we summarize the historical, current and potential future status of kidney transplantation. We discuss three different aspects with a potential significant influence on kidney transplantation progress: the development of surgical techniques, the influence of regenerative medicine and tissue engineering, and changes in immunosuppression. We evaluate the standard open surgical procedures with modern techniques and compare them to less invasive videoscopic as well as robotic techniques. The role of tissue engineering and regenerative medicine as a potential method for future kidney regeneration or replacement and the interesting search for novel solutions in the field of immunosuppression will be discussed. After 60 years since the first successfully performed kidney transplantation, we can conclude that the greatest achievements are associated with the development of surgical techniques and with planned systemic immunosuppression.

show abstract

Section: The Development Of Surgical Methodsmentioning

confidence: 99%

Novel surgical techniques, regenerative medicine, tissue engineering and innovative immunosuppression in kidney transplantation

Nowacki¹,

Nazarewski²,

Kloskowski³

et al. 2016

aoms

View full text Add to dashboard Cite

show abstract

“…The database is one component of the FDA's post‐market surveillance efforts capturing the adverse events observed with a specific device among all types of practitioners. The database has been utilized by other surgical specialties to evaluate devices, but has been used infrequently as a resource in dermatology . A review done by a group of interventional radiologists found new, and conflicting, information when comparing the FDA MDRs to previously published literature .…”

Section: Introductionmentioning

confidence: 99%

FDA MAUDE data on complications with lasers, light sources, and energy‐based devices

Tremaine

Avram

2015

Lasers Surg Med

View full text Add to dashboard Cite

Background and Objective: It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. Study Design/Materials and Methods: We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Results: Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. Conclusion: 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.

show abstract

“…The rate of perioperative complications of robotic surgery was 8.11% in our study, which was close to other reports (14.4% 16 and 8.3% 17). But another paper 18 suggested that 26% of reported events resulted in injury, 8.5% resulted in death, and 21% of injuries were attributed to operator-related error, 14% to technical system failure, 65% were not directly related to use of the robot, so it was important to continue to evaluate the occurrence of injuries during robot-assisted surgery in an effort to identify unique challenges associated with this advanced technology.…”

Section: Discussionmentioning

confidence: 99%

The learning curves of robotic and three-dimensional laparoscopic surgery in cervical cancer

Li¹,

Jiang³

2016

J. Cancer

View full text Add to dashboard Cite

BACKGROUND: The 3D laparoscopy systems and robotic systems have been introduced into clinical practice for a few years. But the comparison of robotic and 3D laparoscopic gynecologic surgery is still needed.OBJECTIVE: To retrospectively compare the learning curves of robotic and 3D laparoscopic hysterectomy and pelvic lymphadenectomy in cervical cancer.STUDY DESIGN: The operational duration, blood loss, peritoneal drainage of first 24 hours after operation, total hospitalization days, hospitalization days after operation, lymph nodes collected, learning curves and cost of robotic and 3D laparoscopic hysterectomy and pelvic lymphadenectomy in cervical cancer performed by one experienced surgeon were studied.RESULTS: There was one surgeon who performed 37 cases of robotic and 24 cases of 3D laparoscopic hysterectomy and pelvic lymphadenectomy, and the turning point of learning curves was case 13th and case 10th. The differences of duration of operation, blood loss, peritoneal drainage of first 24 hours after operation, total hospitalization days, hospitalization days after operation, lymph nodes collected and perioperative complications were not statistically significant. But the cost of each robotic operation was higher than 3D operation.CONCLUSIONS: The turning point of the learning curve of 3D laparoscopic hysterectomy and pelvic lymphadenectomy is earlier than that of robotic sugery in patients with cervical cancer, and there is no obvious benefit from robotic surgery than 3D surgery in the terms of short-term medical index and hospitalization cost.

show abstract

MAUDE: Analysis of Robotic-Assisted Gynecologic Surgery

Cited by 27 publications

References 24 publications

Novel surgical techniques, regenerative medicine, tissue engineering and innovative immunosuppression in kidney transplantation

Novel surgical techniques, regenerative medicine, tissue engineering and innovative immunosuppression in kidney transplantation

FDA MAUDE data on complications with lasers, light sources, and energy‐based devices

The learning curves of robotic and three-dimensional laparoscopic surgery in cervical cancer

Contact Info

Product

Resources

About