MAUDE Adverse Event Report: WICKIMED 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	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not 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.
Event or Problem Description
The customer reported that the plpul2020, ultra surgical smoke evacuation pencil, device was being used on (b)(6) 2025 during a bbr procedure when it was reported ¿towards the end of a long case, the plastic component that holds the electrode has cracked and broken, with shards of plastic found within the wound.The electrode is placed in the holder at the beginning of the case and is not changed or removed.¿.Further assessment found that the fragment was removed from the wound.The procedure was completed with the use of the same alternate device and a 10-minute delay.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the device fragmenting and being retrieved is inconclusive.Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.(b)(4).We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the plpul2020, ultra surgical smoke evacuation pencil, device was being used on (b)(6) 2025 during a bbr procedure when it was reported ¿towards the end of a long case, the plastic component that holds the electrode has cracked and broken, with shards of plastic found within the wound.The electrode is placed in the holder at the beginning of the case and is not changed or removed.¿.Further assessment found that the fragment was removed from the wound.The procedure was completed with the use of the same alternate device and a 10-minute delay.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21969250
• Report Number: 1320894-2025-00132
• Device Sequence Number: 15557222
• Product Code: GEI
• UDI-Device Identifier: 20845854061210
• UDI-Public: (01)20845854061210(17)271217(10)WM20241236
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K230547
• 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): 06/16/2025

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: WM20241236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic