BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL

    MDR report key: 11094425 · Received December 30, 2020

    Report

    Report Number
    1320894-2020-00577
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    November 17, 2020
    Report Date
    February 19, 2021
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO.,LTD
    Product Code
    GEI
    PMA / PMN Number
    K103375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DHR WAS REQUESTED FROM THE MANUFACTURER, HOWEVER, HAS NOT BEEN PROVIDED TO DATE. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE COMPLAINT, REGARDING ONE DEVICE, 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 0.00004. CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER MW5098011. THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE NOT KNOWN. THE PLPUL2520 WAS REPORTED AS BEING USED DURING SURGERY ON (B)(6) 2020 AND "WHILE SURGEON WAS USING THE PLUMEPEN ULTRA, THERE WAS AN ARC THAT CAME FROM THE BOVIE TIP AND HANDPIECE INSIDE THE PLASTIC COVER. NO HARM." THERE WAS NO REPORT OF HARM TO THE PATIENT/USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560162 PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO.,LTD 054320

    Patients

    Seq Age Sex Outcome Treatment
    1 Death