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	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ia-2379, lightwave ablator, 90° angle, 3.2 mm x 150 mm device was being used on (b)(6) 2026 and ¿the ablation tip ruptured at the posterior portion during the acromioplasty procedure while operating at settings of 60 cut / 30 ablation.A fragment detached and fell into the patient; however, it was completely retrieved and removed during the procedure.¿ there was no report of injury, medical intervention or extended hospitalization for the patient or user.The procedure was completed with an alternate same device and there was a 10-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
G3 initial awareness date was 4aug2026.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.

• 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 ; 525 french rd; utica, NY 13502 ; +1(865)388-1978
• MDR Report Key: 50273441
• Report Number: 1320894-2026-00200
• Device Sequence Number: 10346467
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 202601191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 140 LB