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	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the ia-2379, lightwave ablator, 90° angle, 3.2 mm x 150 mm device was used in a bio acromion procedure on (b)(6) 2025, and ¿during the use of the radiofrequency device in a surgical procedure, an event was identified at the beginning of its application.A malfunction occurred, resulting in an abrupt release of energy and subsequent fragmentation of the device¿s active tip while still inside the patient.The procedure was interrupted, and the medical team took the necessary actions to ensure patient safety.Fragments were removed during the procedure.¿.The procedure was completed with the use of another manufacturer¿s device and no delay.Further assessment confirmed that all fragments were removed from the patient.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the ia-2379, lightwave ablator, 90° angle, 3.2 mm x 150 mm device was used in a bio acromion procedure on (b)(6) 2025, and ¿during the use of the radiofrequency device in a surgical procedure, an event was identified at the beginning of its application.A malfunction occurred, resulting in an abrupt release of energy and subsequent fragmentation of the device¿s active tip while still inside the patient.The procedure was interrupted, and the medical team took the necessary actions to ensure patient safety.Fragments were removed during the procedure.¿.The procedure was completed with the use of another manufacturer¿s device and no delay.Further assessment confirmed that all fragments were removed from the patient.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Visual examination of the returned used device, item ia-2379, found the ceramic at the tip broken and the coating (insulation) burned at the ablator head.Broken ceramic was not returned with the device.The electrode appears to have been used based on the condition of the active electrode showing signs of activation.Root cause cannot be determined, however, based upon photos and ifu; a possible cause of this event could be bending forces of the shaft.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 lot history review shows a total of (b)(4) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of four reports, regarding four 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 (b)(4).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 bend electrode shaft, insulation may be damaged.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 23301774
• Report Number: 1320894-2025-00242
• Device Sequence Number: 4783667
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• UDI-Public: (01)10845854040355(17)290331(10)202404011
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 202404011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic