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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problem Blood Loss (2597)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Title: flexible endoscopy assisted by ligasure¿ for treatment of zenker¿s diverticulum: an efective and safe procedure source: surgical endoscopy https://doi.Org/10.1007/s00464-020-08001-9.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study that prospectively analyzed 46 patients who underwent included patients treated by flexible endoscopy using ligasure for resection of zenker¿s diverticulum at a single center between 2009 and 2018 by three endoscopists.After reaching intended position, the ligasure blades were opened and closed, catching the septum.It was coagulated, sealed and finally cut in the middle to 3 mm from the bottom of the diverticulum.This procedure was repeated if some muscle fibers remained uncut.The dissection was considered complete when muscle layer fibers were observed.At the end of the procedure, one or two endoclips were placed at the base of the dissection to and prevent microperforation or bleeding.There was one case of significant bleeding which required endoscopic therapy.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10777537
• MDR Text Key: 214318287
• Report Number: 1717344-2020-01345
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR