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

Catalog Number	PLPUL2520
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, plpul2520, ultra surgical smoke evacuation pencil was being used on (b)(6) 2025 and the "cautery pencil was being used inside open chest.Cautery stopped working for a moment and when examined a small piece of plastic where cautery tip sits broke off and fell into open cavity.Small piece was found.¿ 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
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.
Event or Problem Description
The customer reported that the device, plpul2520, ultra surgical smoke evacuation pencil was being used on (b)(6) 2025 and the "cautery pencil was being used inside open chest.Cautery stopped working for a moment and when examined a small piece of plastic where cautery tip sits broke off and fell into open cavity.Small piece was found.¿ 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
Correction: the aware date reported on the initial submission to the fda was corrected to 23jul25 as new information was received on 18sep25 that changed conmed's aware date.The examination of the returned used device plpul2520 found that part of the hex electrode hub (the part that looks like a ¿c¿) inside the air tube was broken off.The broken piece was returned for evaluation.Root cause cannot be determined, however, based upon evaluation of the device and the ifu; a possible cause of this event could be excessive force.A device history record review was requested from the manufacturer, and no indication of abnormalities was communicated.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 18 reports, regarding 18 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 the following: 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.

• Brand Name: PLUMEPEN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23050377
• Report Number: 1320894-2025-00224
• Device Sequence Number: 15830639
• Product Code: GEI
• UDI-Device Identifier: 20845854061227
• UDI-Public: (01)20845854061227(17)280211(10)WM20250219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: PLPUL2520
• Device Lot Number: WM20250219
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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