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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.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.
Event or Problem Description
The customer reported that the that the plpul2020 ultra surgical smoke evacuation pencil, device was being used on (b)(6) 2025 during a whipple procedure when it was reported ¿the blade holder collapse and telescopic capture port melted during procedure.¿.Further assessment questioning found the device did fragment into the surgical site and was removed with the use of forceps.The procedure was completed with the use of the same alternate device and a 15-minute delay.There was no report of injury, 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
Examination of the returned used device plpul2020 found that the capture port was partly melted from the device.The fragment that broke off from the device was not returned for evaluation.The root cause cannot be determined, however, based upon evaluation, photos, and the risk document, the likely cause of this event was extended activation time at a high amperage.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of one device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the electrosurgical generator¿s intensity should be set as low as is necessary to achieve the desired effect.Plumepen® ultra is a monopolar electrode, the use of a dispersive electrode is required to prevent burns/injury to patient.Please refer to electrosurgical generator user manual and dispersive electrode instructions for use for additional instructions.Intended for use with a maximum voltage of 5 kvp.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the that the plpul2020 ultra surgical smoke evacuation pencil, device was being used on 02dec25 during a whipple procedure when it was reported ¿the blade holder collapse and telescopic capture port melted during procedure.¿.Further assessment questioning found the device did fragment into the surgical site and was removed with the use of forceps.The procedure was completed with the use of the same alternate device and a 15-minute delay.There was no report of injury, 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.

• 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 51600 0; CH 516000
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24055485
• Report Number: 1320894-2026-00014
• Device Sequence Number: 18578207
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)271115(10)WM20241126
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: WM20241126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic