MAUDE Adverse Event Report: CONMED UTICA LINVATEC H/C LIGHTWAVE ABLATOR; GEI - ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	IA-2379
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note this report is being resubmitted following an unsuccessful submission attempt on (b)(6) 2021 due to a system error.The reported event of ¿tip of the product melted¿ is confirmed.Visual examination of the returned used device found the coating (insulation) burned at the ablator head.The tip ceramic appears to be intact.The device appears to have been used based on the condition of the electrode showing signs of activation.Examination performed; no other discrepancies were found.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 was found to have met all specifications prior to shipment.A 2 year lot history review found 2 events for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 8 complaints, regarding 10 devices, for this device family and failure mode.During this same time frame 44,189 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 0.0002.Per the instructions for use, the user is advised the following: if any visual defects are noticed in the insulation, or the ceramic/insulation is damaged in any way, stop using the device immediately and replace the device.Examine all accessories and connections to the generator before use.Lightwave ablators must only be used in a conductive fluid medium to avoid insulation damage.High power generator settings, and prolonged use, may result in damage to the insulation, melting of the electrode tip or increased risk of patient burns.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the ia-2379, lightwave ablator was used in a video arthroscopy procedure on (b)(6) 2021.According to the customer, ¿the tip of the product, melted.¿ the procedure was completed using another of the same device.There was no surgical delay reported.There was no injury or impact to the male patient reported.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: LINVATEC H/C LIGHTWAVE ABLATOR
• Common Device Name: GEI - ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12411266
• Report Number: 1320894-2021-00355
• Device Sequence Number: 3661748
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• UDI-Public: (01)10845854040355(17)231125(30)1(10)201811261
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2023
• Device Catalogue Number: IA-2379
• Device Lot Number: 201811261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1