MAUDE Adverse Event Report: WICKIMED SUPPLY COMPANY LIMITED 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	07/02/2025
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
A distributor reported on behalf of a customer that the plp2020, elite surgical smoke evacuation pencil device was used in an unknown procedure on (b)(6) 2025, and ¿plastic piece that suctions smoke broke off handpiece.No injuries.¿.The procedure was completed with the use of an alternate device and ¿no significant delay¿.Further assessment found it is unknown whether any fragment or component fell into the surgical site.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the injury of a possible retained foreign body.
Event or Problem Description
A distributor reported on behalf of a customer that the plp2020, elite surgical smoke evacuation pencil device was used in an unknown procedure on (b)(6) 2025, and ¿plastic piece that suctions smoke broke off handpiece.No injuries.¿.The procedure was completed with the use of an alternate device and ¿no significant delay¿.Further assessment found it is unknown whether any fragment or component fell into the surgical site.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised due to the injury of a possible retained foreign body.
Additional Manufacturer Narrative
Examination of returned used device plp2020 found that the plastic tube above where the electrode blade goes had broken off and became disconnected from the rest of the device.Examination was done per (b)(4), plumepen elite surgical smoke evacuation pencil instructions for use.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be the use of excessive force.A two-year lot history review shows a total of (b)(4) device 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 (b)(4) 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).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 SUPPLY COMPANY LIMITED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED SUPPLY COMPANY LIMITED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22586084
• Report Number: 1320894-2025-00179
• Device Sequence Number: 9282652
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)270919(10)WM20240936
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: PLP2020
• Device Lot Number: WM20240936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic