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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, plpul2020, ultra surgical smoke evacuation pencil, was being used during a gyn procedure on (b)(6) 2025 when it was reported, ¿during a case with dr.Viau in gynecology, the plumepen ultra broke when he tried to unclip it to lengthen it.A piece fell into the patient, and was later found.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed using an alternate device which caused a 5-minute delay.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.H3 other text : device not yet received.
Additional Manufacturer Narrative
Examination of the returned used device plpul2020 found that a piece of the plumepen ext front was broken off and would not lock it into place.The broken piece was not returned for evaluation.Visual examination was done with the help of print (b)(4).The root cause cannot be determined, however, based upon evaluation, photos, and the risk document, the likely cause of this event was 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 43 complaints, regarding 61 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).We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, plpul2020, ultra surgical smoke evacuation pencil, was being used during a gyn procedure on (b)(6) 2025 when it was reported, ¿during a case with dr.(b)(6) in gynecology, the plumepen ultra broke when he tried to unclip it to lengthen it.A piece fell into the patient and was later found.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed using an alternate device which caused a 5-minute delay.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, prc 51600 0; CH 516000
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23848202
• Report Number: 1320894-2025-00289
• Device Sequence Number: 21218285
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)280414(10)WM20250430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/30/2026

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: WM20250430
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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