BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLPUL2020, 20/CA ULTRA NONSTICK 10FT

    MDR report key: 11282411 · Received February 4, 2021

    Report

    Report Number
    1320894-2021-00051
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    December 30, 2020
    Report Date
    March 4, 2021
    Manufacturer
    ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO.,LTD
    Product Code
    GEI
    PMA / PMN Number
    K103375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS INCONCLUSIVE. THE DEVICE IS NOT BEING RETURNED AND NO PHOTOGRAPH EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE DHR WAS NOT LOCATED. 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 TWO COMPLAINTS, REGARDING TWO 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). 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

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, 20/CA ULTRA NONSTICK 10FT DEVICE WAS BEING USED DURING A COLECTOMY PROCEDURE ON (B)(6) 2020 WHEN IT WAS REPORTED THAT "DR. (B)(6) WAS WORKING IN A TIGHT SPACE USING THE PELVIS, AND DUE TO LACK OF VISION OF OUR ULTRA SMOKE EVACUATION PEN TIP, HE ACCIDENTALLY BURNED SOME MUSCLE, MISSING THE TARGET TISSUE HE WAS AIMING FOR. THE PATIENT IS OK." UPON FURTHER ASSESSMENT, IT WAS FOUND DR (B)(6) WANTED TO HAVE SOMETHING ON RECORD THAT THE PENCIL WAS NOT EVACUATING SMOKE. THERE WAS NO DELAY TO THE SURGERY. THE PROCEDURE WAS COMPLETED WITH A PLP2020 DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNINTENDED BURNING OF MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178412 PLPUL2020, 20/CA ULTRA NONSTICK 10FT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO.,LTD 090920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other