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

Catalog Number	PLPUL2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
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.H3 other text: device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, plpul2020, ultra surgical smoke evacuation pencil, was being used during an open liver procedure on (b)(6) 2025 when it was reported, ¿the inner plastic of the pencil (where the diathermy tip attaches to the handpiece) snapped while attaching the tip.¿.Further assessment was requested from the reporter.The statement received read, ¿i know for certain the guarded electrode tip fell into the abdomen and was retrieved promptly by hand.I cannot say for certain if any other piece of plastic from the plume pen fell into the cavity or not.If it did, this was not retrieved.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was reported as having been completed as planned.This report is being raised due to the reported injury of possible foreign body left in patient.
Additional Manufacturer Narrative
Examination of the returned used device, item plpul2020 performed per procedure pdd1742904 found handpiece damaged at the tip.Electrocautery blade was detached from the pencil and was not returned for evaluation.Wire was cut from the handpiece.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.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.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 (b)(4) complaints, regarding (b)(4) 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 device, plpul2020, ultra surgical smoke evacuation pencil, was being used during an open liver procedure on (b)(6) 2025 when it was reported, ¿the inner plastic of the pencil (where the diathermy tip attaches to the handpiece) snapped while attaching the tip.¿.Further assessment was requested from the reporter.The statement received read, ¿i know for certain the guarded electrode tip fell into the abdomen and was retrieved promptly by hand.I cannot say for certain if any other piece of plastic from the plume pen fell into the cavity or not.If it did, this was not retrieved.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was reported as having been completed as planned.This report is being raised due to the reported injury of possible foreign body left in patient.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23788098
• Report Number: 1320894-2025-00277
• Device Sequence Number: 5712698
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)280525(10)WM20250536
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLPUL2020
• Device Lot Number: WM20250536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic