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

Catalog Number	PLP2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
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
This complaint was created due to the receipt of a medwatch report (mw5178497) received on 24nov2025.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the plp2020, elite surgical smoke evacuation pencil.The incident occurred on (b)(6) 2025.The report states that the "smoke evac pencil plastic sheath broke into pieces during surgery.Surgeons had to stop and find pieces." the health effect: clinical code was reported as 4580: insufficient information.It was not reported if all the pieces were successfully removed from the patient and as the reporter elected to remain anonymous, this information cannot be obtained.This report is being raised due to the reported injury of possible retained foreign body.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.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 10 reports, 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 the following: above the electrode blade is a translucent plastic tube that can be positioned at varying lengths to effectively capture the surgical smoke plume as it is created.With the electrosurgical generator off and the electrode blade cool, position this tube as near the point of the tissue interaction as possible without obstructing the view of the target tissue.Keep the active electrodes clean.Build-up of eschar may reduce the instrument¿s effectiveness.Do not activate the instrument while cleaning.Injury to operating room personnel may result.Additionally, the ifu also advises the user that if original blade is removed, visually confirm new blade is completely inserted and secured before activating the pencil.Never force the blade into the pencil.Rotate the pencil if the smoke tube is obstructing view of the insertion point.Inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5178497) received on 24nov2025.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the plp2020, elite surgical smoke evacuation pencil.The incident occurred on (b)(6) 2025.The report states that the ¿smoke evac pencil plastic sheath broke into pieces during surgery.Surgeons had to stop and find pieces.¿ the health effect - clinical code was reported as 4580: insufficient information.It was not reported if all the pieces were successfully removed from the patient and as the reporter elected to remain anonymous, this information cannot be obtained.This report is being raised due to the reported injury of possible retained foreign body.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23766946
• Report Number: 1320894-2025-00270
• Device Sequence Number: 21473385
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)270707(10)WM20240716
• 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: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: PLP2020
• Device Lot Number: WM20240716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic