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

Catalog Number	PLPUL2020
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device plpul2020, ultra surgical smoke evacuation pencil was being used on (b)(6) 2026 during a closure of ileostomy and ¿cautery pen used in surgical case goes off even when surgeon does not press button to activate cautery pen.Potential for patient harm.¿ there was no impact or injury to 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 19jun26.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): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: robin drum ; 525 french rd; utica, NY 13502 ; 8653881978
• MDR Report Key: 25779467
• Report Number: 1320894-2026-00175
• Device Sequence Number: 9607997
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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: WM20250857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 08/12/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown