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

Catalog Number	PLPUL2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction

• Brand Name: PLUMEPEN
• 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: john berga ; 525 french rd.; utica, NY 13502 ; +1(727)399-5358
• MDR Report Key: 25853155
• Report Number: 1320894-2026-00180
• Device Sequence Number: 5205038
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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: PLPUL2020
• Device Lot Number: WM20251028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male