MAUDE Adverse Event Report: COVIDIEN LIGASURE IMPACT CURVED LARGE JAW OPEN SEALER/DIVIDER, 36MM X 18CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number LF4418

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

A (b)(6) f to operating room for laparotomy exploratory, tah with bso, tumor debulking, cystoscopy w/stent placement and removal.During the case, the large jaw open sealer, curved was found to be defective and swapped out for a new device.No harm to the patient.Fda safety report id# (b)(4).

• Brand Name: LIGASURE IMPACT CURVED LARGE JAW OPEN SEALER/DIVIDER, 36MM X 18CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13424963
• MDR Text Key: 285013783
• Report Number: MW5107133
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF4418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female