MAUDE Adverse Event Report: CONMED UTICA LIGHTWAVE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	IA-2379
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, ia-2379, lightwave ablator, 90° angle was being used on (b)(6)2024 and ¿during the use of rf, the device's protective sheath melts, causing no injury to the patient.¿.Per further assessment it was found that "a piece of the device broke and was removed from the patient; however, a second surgery was not required.".There was no impact or injury for the patient.The procedure was completed with an alternate same device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of the customer that the device, ia-2379, lightwave ablator, 90° angle was being used on (b)(6) 2024 and ¿during the use of rf, the device's protective sheath melts, causing no injury to the patient.¿.Per further assessment it was found that "a piece of the device broke and was removed from the patient; however, a second surgery was not required.".There was no impact or injury for the patient.The procedure was completed with an alternate same device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the device melting is confirmed.The device will not be returned; however photographic evidence was provided.The root cause cannot be determined, however, based upon the photos and the guidance from the ifu along with the event description, the likely cause of this event was that the insulation was activated while not surrounded by conductive fluid.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.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 two-year review of complaint history revealed there has been a total of 32 reports, regarding 34 devices, for this device family and failure mode.During this same time frame 52,132 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 0.0007.Per the instructions for use, the user is advised the following: lightwave ablators must only be used in a conductive fluid medium to avoid insulation damage.Use ablators only within prescribed generator settings.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.Do not bury electrode tip and insulator in tissue.The electrode tip must be completely surrounded by conductive fluid when activated in order to avoid damage to the insulation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: LIGHTWAVE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 21206635
• Report Number: 1320894-2025-00023
• Device Sequence Number: 20872350
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• UDI-Public: (01)10845854040355(17)280909(10)2023091111
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Catalogue Number: IA-2379
• Device Lot Number: 2023091111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic