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

Catalog Number	PLP2020
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty(b)(4) device was being used on 30may24, and the ¿bovie would not shut off¿.Further assessment found the event occurred during a "spine procedure (not specified)".An unknown alternate device was used and there was no reported delay to the procedure.There was no injury to the patient or user, and no medical/surgical intervention or extended hospitalization was required for the patient.This report is being raised on the basis of 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
Correction: brand name has been corrected in section d.1.Additional manufacturer narrative: the device will not be returned and no photographic evidence was provided therefore, a device malfunction cannot be verified.Vendor inspection of retains found that they could not reproduce the reported event as retain samples performed as expected.A device history record review was requested from the manufacturer and no indication of abnormalities was communicated.A 2 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 91 reports, regarding 101 devices, for this device family and failure mode.During this same time frame 4,320,715 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 0.00002.Per the instructions for use, the user is advised the following: 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 for trends through the complaint system to assure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the plp2020, plumepen elite surgical smoke evac pencil, 10ft tubing,qty20 device was being used on 30may24, and the ¿bovie would not shut off¿.Further assessment found the event occurred during a "spine procedure (not specified)".An unknown alternate device was used and there was no reported delay to the procedure.There was no injury to the patient or user, and no medical/surgical intervention or extended hospitalization was required 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 industrial area; lilin, huizhou, prc 51600 0; CH 516000
• Manufacturer (Section G): WICKIMED SUPPLY COMPANY LIMITED; 4-5/f, building b; tangjiao industrial area; lilin, huizhou 51600 0; CH 516000
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19704889
• Report Number: 1320894-2024-00173
• Device Sequence Number: 12760171
• Product Code: GEI
• UDI-Device Identifier: 10845854061282
• UDI-Public: (01)10845854061282(17)260205(10)WM20230203
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K230547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Expiration Date: 02/05/2026
• Device Catalogue Number: PLP2020
• Device Lot Number: WM20230203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic