MAUDE Adverse Event Report: CONMED CORPORATION ELECTRODE BLADE LONG INSULATED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 138110

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/09/2018

Event Type  malfunction  

Manufacturer Narrative

Complaint of crack/ break in insulation is confirmed.The device has not been returned for evaluation however the provided photographic evidence exhibits the reported failure however, photographs of the burn site were not provided.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 3 complaints regarding 3 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; these devices should be inspected before and after each use.Visually examine the devices for obvious physical damage including; cracked, broken or otherwise distorted plastic parts; damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration; inspect and test each device before each; verify that the electrode is full and securely seated in the handpiece before use; activation time should be as short as possible.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported the 138110, electrode caused a burn to the patient's skin on (b)(6) 2018 during a breast augmentation surgery, due to having a crack in the insulation.The burn area was excised by the surgeon as part of the procedure.The burn occurred on the left breast, the area where surgery was being performed.The procedure was completed as planned.There were no pictures of the burn since it was incorporated into the original incision.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: ELECTRODE BLADE LONG INSULATED
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8445637
• MDR Text Key: 143443789
• Report Number: 1320894-2019-00057
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405003458
• UDI-Public: (01)10653405003458(17)230318(30)40(10)201803191
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K943542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Catalogue Number: 138110
• Device Lot Number: 201803191
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1