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

Catalog Number	PLP1020
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the plp1020 elite surgical smoke evacuation pencil device was being used on (b)(6) 2026 during a circumcision procedure when it was reported ¿dr.Had been using a bovie for approximately for 1 hour and then she felt a zap and quickly put down the bovie.Her hand finger was hurting and when she removed her glove, she noticed small burn mark and a reddened area.¿.Further assessment found that surgeon was not diagnosed with burn severity (no patient impact only surgeon).Burn located on right index finger.Not treatment reported - mentioned redness and sore.Patient status - unaffected (surgeon experienced burn).There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
G3 initial awareness date was 14 may 2026.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: PLUMEPEN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc, 51600 0; CH 516000
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 25392236
• Report Number: 1320894-2026-00136
• Device Sequence Number: 17493969
• Product Code: GEI
• UDI-Device Identifier: 10845854061268
• UDI-Public: (01)10845854061268(17)271108(10)WM20241119
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: PLP1020
• Device Lot Number: WM20241119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown