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

Catalog Number	PLP2520
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, plp2520, elite surgical smoke evac pencil,7/8" (22mm),15ft.(4.6m), was being used during a liver transplant procedure on (b)(6) 2024 when it was reported, ¿a plume pen diathermy short circuited during surgery.We were doing a liver transplant surgery when during the procedure, the surgeon's diathermy pen short circuited.The operating surgeon who was using the diathermy pen felt a small shock after the use.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned using an alternate same device.There was no report of any procedure delays.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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 for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Received one plp2520 in unopened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the esu system 7550, the cut and coag functions as intended when the buttons are pressed.The device does not short out or shock.Additionally, vendor review of reserve samples found no similar problems.A device history record review was requested from the manufacturer and no indication of abnormalities was communicated.This is the only complaint for this lot number and failure mode within the past two years.A (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.Insulation failures may result in burns or other injuries to the patient or operator.Do not activate the instrument when not in contact with target tissue, as this may cause injuries due to capacitive coupling.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, plp2520, elite surgical smoke evac pencil,7/8" (22mm),15ft.(4.6m), was being used during a liver transplant procedure on (b)(6) 2024 when it was reported, ¿a plume pen diathermy short circuited during surgery.We were doing a liver transplant surgery when during the procedure, the surgeon's diathermy pen short circuited.The operating surgeon who was using the diathermy pen felt a small shock after the use.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned to use an alternate same device.There was no report of any procedure delays.This report is being raised due to 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20342820
• Report Number: 1320894-2024-00259
• Device Sequence Number: 7842210
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)270126(10)WM20240165
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: PLP2520
• Device Lot Number: WM20240165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic