MAUDE Adverse Event Report: CONMED CONMED; Electrosurgical, cutting & coagulation & accessories

Catalog Number	AES-90SN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• Brand Name: CONMED
• 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: 50073674
• Report Number: 1320894-2026-00187
• Device Sequence Number: 13313628
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)300209(10)202502101
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2026

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: AES-90SN
• Device Lot Number: 202502101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/24/2026; 09/01/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/31/2026; 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown