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	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the plpul2020 ultra surgical smoke evacuation pencil, device was being used on (b)(6) 2026 during an unknown procedure when it was reported ¿electrode insertion port on pencil cracked and electrode fell in wound.¿ further assessment questioning found that the fragment was retrieved from the surgical site.The procedure was completed with the use of the same alternate device and a 5-minute delay was reported.There was no report of injury, medical intervention or extended stay for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the 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: 25182616
• Report Number: 1320894-2026-00129
• Device Sequence Number: 10692992
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)280927(10)WM20250965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: WM20250965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown