MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1212A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: reduced morbidity by using ligasure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: a randomized controlled trial.Source: surgical oncology volume 35, december 2020, pages 149-15.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature study, between october 2017 and october 2018, 20 patients with 40 groins requiring bilateral inguinofemoral lymphadenectomy (ifl) were included in this study.Ten patients were allocated to ifl with ligasure in the right groin and ten patients were allocated to ligasure in the left groin.Postoperative short-term complications requiring treatment occurred in 6/20 groins treated with ligasure: 1 wound infection; 4 wound infection and lymphocele.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 10789314
• Report Number: 1717344-2020-01359
• Device Sequence Number: 11676729
• Product Code: GEI
• UDI-Device Identifier: 10884521186033
• UDI-Public: 10884521186033
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K152286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other