MAUDE Adverse Event Report: MODERN MEDICAL EQUIP MFG LTD PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	PLP2520
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the plp2520 was being used and the ¿cautery unit stayed on¿.There was no report of impact/injury, medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported 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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the plp2520 was being used and the "cautery unit stayed on".There was no report of impact/injury, medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one plp2520 in opened original packaging.The lot number returned was mm20221106.Performed a visual inspection, the coagulation button is concaved making continuous contact with the circuit board.Performed a functional inspection using the esu system 7550, the coagulation continuously activates without pressing the buttons.A likely cause of this event may be due to fluid ingress in the button area of the device.A 2 year lot history review shows a total of 6 devices for this lot number and failure mode; however, none are confirmed.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 review of complaint history revealed there has been a total of 196 reports, regarding 698 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 the following: inspect instruments and cables for damage prior to each use, especially the insulation of laparoscopic/endoscopic instruments.The electrode tip may remain hot enough to cause burns after the current has been de-activated.Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.Localized burns to the patient or physician may result from electrical currents carried through conductive objects.Current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory being in close proximity to the conductive object.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer (Section G): MODERN MEDICAL EQUIP MFG LTD; unit a, 10/f mai wah ind bldg; 1-7 wah sing street; kwai chung, nt ; HK
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19010331
• Report Number: 1320894-2024-00086
• Device Sequence Number: 3809525
• Product Code: GEI
• UDI-Device Identifier: 10845854061305
• UDI-Public: (01)10845854061305(17)251103(10)MM20221106
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/06/2024

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: 11/03/2025
• Device Catalogue Number: PLP2520
• Device Lot Number: MM20221106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic