MAUDE Adverse Event Report: CONMED UTICA ESP ACCESSORY BALL 5MM; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number 60-5181-103

Device Problems Fire (1245); Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmeds complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of their customer ethicon reported issues with the 60-5181-103 esp accessory ball 5mm electrode, lot 201910071, that was experienced prior to (b)(6) 2020.Information received indicates it was reported by the sales rep that the issue occurred during an unknown procedure.They received an email stating the following we recently switched esus from medtronic ft-10 to the conmed 2450 esu while still using ethicon megasoft grounding pads and since the switch we have been experiencing sparking and flame issues from the pencil tips while using megasoft pads.It was noted there were three incidents, and the information infers that they occurred prior to (b)(6).No megasoft serial numbers from these incidents were recorded.The account is not blaming the incident on the pads but are looking into all possible factors.To date, additional information has been requested multiple times, but no information has been received.This incident will be reported on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported event is unconfirmed.Although the device was returned for device evaluation no photographic evidence of the event was provided and there are no indications from the returned electrode that it was involved in an arcing/sparking event.Conmed received one 60-5181-103 opened in unoriginal packaging.The label from the original packaging was returned.An unidentified pencil was also returned.The lot number of the device - 201910071 was verified based on the returned packaging.A visual inspection found small abrasions on the internal end of the electrode.The returned pencil did not have any obvious defects or abnormalities.A functional test was performed using the returned 60-5181-103 and pencil with the esu (c8406).The cut and coag modes were tested and the electrode successfully energized.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found this is the only complaint this lot number and failure mode.A two-year review of complaint history for similar failure modes revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.000001.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is advised that use of aspen lee electrodes is contraindicated in the presence of flammable gases, flammable prep solutions or drapes, oxidizing gases such as nitrous oxide (n2o) or in oxygen-enriched environments.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of their customer ethicon reported issues with the 60-5181-103 esp accessory ball 5mm electrode, lot 201910071, that was experienced prior to november 2020.Information received indicates ¿it was reported by the sales rep that the issue occurred during an unknown procedure.They received an email stating the following ¿we recently switched esu¿s from medtronic ft-10 to the conmed 2450 esu while still using ethicon megasoft grounding pads and since the switch we have been experiencing sparking and flame issues from the pencil tips while using megasoft pads.It was noted there were three incidents, and the information infers that they occurred prior to 09november.No megasoft serial numbers from these incidents were recorded.The account is not blaming the incident on the pads but are looking into all possible factors.To date, additional information has been requested multiple times, but no information has been received.This incident will be reported on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ESP ACCESSORY BALL 5MM
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12159788
• MDR Text Key: 261272359
• Report Number: 1320894-2021-00319
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• PMA/PMN Number: K913213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-5181-103
• Device Lot Number: 201910071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONMED 2450 ESU; CONMED 2450 ESU; MEGASOFT GROUNDING PADS; MEGASOFT GROUNDING PADS; CONMED 2450 ESU; MEGASOFT GROUNDING PADS