MAUDE Adverse Event Report: WICKIMED 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	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint was created by the finding of maude report number mw5171145.The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The plp2020, elite surgical smoke evacuation pencil was being used on (b)(6) 2025 and the ¿smoke evacuator bovie pencil broke during procedure.Plastic piece that suctions smoke broke a small piece of plastic was found but another piece was not found.¿.The reporter elected to remain anonymous; therefore, no further information can be obtained regarding the event.This report is being raised due to the reported injury of ¿piece of plastic was not found¿ that may potentially remain in the patient.
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.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.This is the only complaint for this lot number and failure mode within the past two years.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.(b)(4).Per the instructions for use, the user is advised the following: the plumepen® elite is equipped with several key features for the surgeon¿s convenience.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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created by the finding of maude report number mw5171145.The account and contact information for this report are not known.The current complaint database has been researched for this event and there were no findings.The plp2020, elite surgical smoke evacuation pencil was being used on (b)(6) 2025 and the ¿smoke evacuator bovie pencil broke during procedure.Plastic piece that suctions smoke broke a small piece of plastic was found but another piece was not found.¿.The reporter elected to remain anonymous; therefore, no further information can be obtained regarding the event.This report is being raised due to the reported injury of ¿piece of plastic was not found¿ that may potentially remain in the patient.

• 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: 22840588
• Report Number: 1320894-2025-00203
• Device Sequence Number: 18467982
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)270328(10)WM20240360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: WM20240360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2024
• 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): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic