MAUDE Adverse Event Report: CONMED 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	06/19/2026
Type of Reportable Event	Malfunction

• Brand Name: LIGHTWAVE
• Common Device Name: Electrosurgical, cutting & coagulation & accessories
• Manufacturer (Section D): CONMED; 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: 50273490
• Report Number: 1320894-2026-00201
• Device Sequence Number: 18728626
• 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: Foreign,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: 33 YR
• Patient Sex: Female
• Patient Weight: 136 LB