MAUDE Adverse Event Report: CONMED CORPORATION LAPAROSCOPIC ELECTRODE; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number 60-5163-001

Device Problems Therapeutic or Diagnostic Output Failure (3023); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2020

Event Type  malfunction  

Event Description

Conmed l hook used for lap chole did not cauterize when utilized as desired noted surgeon.Replaced with different l hook which worked as needed.When removed from field noted that the insulation at tip of l hood was slightly split.

• Brand Name: LAPAROSCOPIC ELECTRODE
• Type of Device: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 16859879
• MDR Text Key: 314461744
• Report Number: 16859879
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-5163-001
• Device Catalogue Number: 60-5163-001
• Device Lot Number: 202006161
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Sex: Male