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

Catalog Number	PLPUL2520
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the plpul2520, ultra surgical smoke evacuation pencil device was used in an ogd & total gastrectomy procedure on (b)(6) 2025, and ¿the plastic part of the diathermy tip extension was broken whilst using for surgery¿.Further assessment found that, "on the plume-pen, there is a plastic attachment continuing from the diathermy tip to the pen, this plastic connection was displaced/ broken/ separated/ not in continuity.When noticed, the broken piece was still inside the pen.The site was thorough inspected and nothing found.Malfunctioned instrument had no effect on patient¿s surgical outcome".The procedure was completed as normal with an alternate same device and a delay of two minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
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 one device for this lot number and failure mode.A device history record review was requested from the manufacturer, and no indication of abnormalities was communicated.(b)(4).Per the instructions for use, the user is advised 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
A customer reported that the plpul2520, ultra surgical smoke evacuation pencil device was used in an ogd & total gastrectomy procedure on (b)(6) 2025, and ¿the plastic part of the diathermy tip extension was broken whilst using for surgery¿.Further assessment found that, "on the plume-pen, there is a plastic attachment continuing from the diathermy tip to the pen, this plastic connection was displaced/broken/separated/not in continuity.When noticed, the broken piece was still inside the pen.The site was thorough inspected and nothing found.Malfunctioned instrument had no effect on patient¿s surgical outcome".The procedure was completed as normal with an alternate same device and a delay of two minutes.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PLUMEPEN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): WICKIMED SUPPLY COMPANY LIMITED; 4-5/f, building b; tangjiao; 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: 22608454
• Report Number: 1320894-2025-00180
• Device Sequence Number: 5384364
• Product Code: GEI
• UDI-Device Identifier: 20845854061227
• UDI-Public: (01)20845854061227(17)280303(10)WM20250304
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: PLPUL2520
• Device Lot Number: WM20250304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic