MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN MAE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK GEN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Citation: sasaki et al; fujiki, m.M.D.; diago uso, t, m.D.; quintini, c.M.D.; miller, m.D., c; hashimoto, m.D., ph.D., k and hyuck david kwon, m.D., ph.D., c; seamless introduction of a purely laparoscopic full-lobe living donor hepatectomy program in a north american center : liver transplantation, vol.27, no.8, 2021; doi 10.1002/lt.26030.Background: at the cleveland clinic, the laparoscopic donor hepatectomy program commenced in august 2019, and they successfully performed 18 laparoscopic full-lobe donor hepatectomy (lfdh) cases during a subsequent 12-month period.The purpose of this study was to elaborate their understanding of the prerequisites for the successful initiation of such a program and share their early experiences.Methods: this study was approved by the institutional review board of cleveland clinic (institutional review board no.19-1146).An average of 15 living donor liver transplants, all performed by the open approach, were being performed annually at our institution.Laparoscopic liver resection (llr) for oncological indications was also undertaken albeit mostly minor resections.However, during the 9-month period before commencing lfdh, major modifications were undertaken to ensure the safe and seamless induction of the lfdh program.Results: there were no major complications, and 1 patient developed a postoperative surgical wound infection (clavien-dindo grade ii).Conclusions: they wereable to achieve successful implementation of the laparoscopic approach.An important aspect and catalyst of the success of our program was attributed to the recruitment of the senior author, who had extensive experience in lfdh.However, this study demonstrates many other important facets in the implementation of this program.The importance of building up a dedicated surgical team, assuring institutional support for optimization of surgical equipment, selecting donors judiciously, and planning for a comprehensive disaster cannot be underestimated.Reportable events: it was reported that there were no major complications, and 1 patient developed a postoperative surgical wound infection (clavien-dindo grade ii).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN MAE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15597136
• MDR Text Key: 301665588
• Report Number: 1226420-2022-00043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK GEN
• Device Catalogue Number: MAE UNK GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention