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

Catalog Number	PLPUL2020
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
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.
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 there was ¿significant interference generated by the electrocautery, preventing the emg (evoked potential) device from functioning properly.Consequence: loss of confidence in the emg device, patient had to be awakened quickly to check for any impairments.Result: slight impairments, which may be temporary or permanent.Occurred at the end of a scoliosis case, during closure.Generator used ft10.Generator ft10 was activated for 5 minutes without noticing which interfered with ecg reading, account is wondering if there was a malfunction with electrosurgical pen as that activated itself or if the staff activated it without noticing because the energy alarm sound was too low on the generator.¿.The procedure was completed without the use of an alternate device.There was a delay of ¿30+ minutes¿.Further information has been requested; however, to date, a reply has not been received.This report is being raised due to the reported injury of slight impairments.
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 there was ¿significant interference generated by the electrocautery, preventing the emg (evoked potential) device from functioning properly.Consequence: loss of confidence in the emg device, patient had to be awakened quickly to check for any impairments.Result: slight impairments, which may be temporary or permanent.Occurred at the end of a scoliosis case, during closure.Generator used ft10.Generator ft10 was activated for 5 minutes without noticing which interfered with ecg reading, account is wondering if there was a malfunction with electrosurgical pen as that activated itself or if the staff activated it without noticing because the energy alarm sound was too low on the generator.¿.The procedure was completed without the use of an alternate device.There was a delay of ¿30+ minutes¿.Further information has been requested; however, to date, a reply has not been received.This report is being raised due to the reported injury of slight impairments.
Additional Manufacturer Narrative
Examination of returned used device plpul2020 found that the device worked as intended.Examination was done with system 5000.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 15 reports, regarding 15 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised the following: inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.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: 21737687
• Report Number: 1320894-2025-00088
• Device Sequence Number: 20991502
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)271107(10)WM20241108
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: WM20241108
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR FT10; GENERATOR FT10
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic