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

Catalog Number	PLP2020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the plp2020, elite surgical smoke evacuation pencil, was being used on (b)(6) 2025 during a tonsillectomy procedure when it was reported ¿no patient impact but physician did get shocked in the hand.He did double check his glove and no hole in his glove.¿ further assessment questioning found ¿all involved are fine.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.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 plp2020, elite surgical smoke evacuation pencil, was being used on (b)(6) 2025 during a tonsillectomy procedure when it was reported ¿no patient impact but physician did get shocked in the hand.He did double check his glove and no hole in his glove.¿.Further assessment questioning found ¿all involved are fine.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: the medical device problem code section h6 was changed from c76126 to c133527.The reported event of the device shocking the user is unconfirmed.Examination of the returned used device plp2020 found that during testing there was no electrical shock.The plumpen worked as intended with no fault found during testing.However the electrode the customer sent back was covered with an unidentified dark substance.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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 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).Per the instructions for use, the user is advised to inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21321106
• Report Number: 1320894-2025-00039
• Device Sequence Number: 15486072
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)270731(10)WM20240801
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: PLP2020
• Device Lot Number: WM20240801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic