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	11/21/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the plpul2020 ultra surgical smoke evacuation pencil device was being used during a breast augmentation procedure on (b)(6) 2025 when it was reported ¿plpul2020 plastic electrode holder snapped during use.¿.Further assessment questioning found that ¿no fragments were reported to have fallen into surgical site.The issue occurred when cleaning the tip of an electrode, this electrode was not the electrode that the plpul2020 has fitted when packaged.The tip was changed during the procedure.The plastic housing that secures the tip was reported to have been "broken.¿ the procedure was completed without the use of an alternate device and there was a 5-minute delay reported.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
Reported event of ¿plastic electrode holder snapped during use¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.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.A two-year review of complaint history revealed there has been a total of 38 complaints, regarding 47 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that if necessary to remove blade, unplug the pencil.Ensure that cam is in the lock position.Use a surgical clamp and pull blade forward.Replace with blade of choice.Confirm that blade is completely inserted and secure before activating pencil.Never force the blade into the pencil.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the plpul2020 ultra surgical smoke evacuation pencil device was being used during a breast augmentation procedure on (b)(6) 2025 when it was reported ¿plpul2020 plastic electrode holder snapped during use.¿ further assessment questioning found that ¿no fragments were reported to have fallen into surgical site.The issue occurred when cleaning the tip of an electrode, this electrode was not the electrode that the plpul2020 has fitted when packaged.The tip was changed during the procedure.The plastic housing that secures the tip was reported to have been "broken.¿ the procedure was completed without the use of an alternate device and there was a 5-minute delay reported.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: 23815323
• Report Number: 1320894-2025-00282
• Device Sequence Number: 15978665
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)280303(10)WM20250319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: WM20250319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic