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	11/06/2025
Type of Reportable Event	Malfunction
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 plpul2020, ultra surgical smoke evacuation pencil was being used on (b)(6) 2025 and ¿¿using the ultra and the piece inside the ultra broke off when swapping out the electrode¿" there was no report of impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: section d3 updated manufacturer narrative: examination of the returned used device plpul2020 found that no broken piece was found in the device.Tried fitting an electrode into the device and the electrode fit as intended.Cord was cut by customer before returning.No fault was found with this device.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 34 reports, regarding 36 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.
Event or Problem Description
Update received on 5dec2025: the procedure was a multilevel posterior spine fusion.The device did not fragment."a component failed.The tip was swapped out before the procedure began and then 60 later the housing for the tips cracked during the procedure and this caused the tip to feel less secure and wobble withing the housing.This was noticeable to the surgeon and he felt it unsafe for the continue with the broken device." the procedure was completed with a 5 minute delay.The sales representative reported on behalf of the customer that the plpul2020, ultra surgical smoke evacuation pencil was being used on (b)(6) 2025 and ¿using the ultra and the piece inside the ultra broke off when swapping out the electrode." there was no report of impact or injury to the patient.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.; tangjiao industrial area; 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: 23580546
• Report Number: 1320894-2025-00263
• Device Sequence Number: 9222833
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)280514(10)WM20250518
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: PLPUL2020
• Device Lot Number: WM20250518
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic