BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW 4 RACHETED HANDPIECE, 34CM

    MDR report key: 17984723 · Received October 23, 2023

    Report

    Report Number
    1223422-2023-00034
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 2, 2022
    Report Date
    October 20, 2023
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099010579
    PMA / PMN Number
    962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO A LACK OF COMMUNICATION, THIS ADVESRE EVENT OCCURED ON (B)(6) 2022 BUT WAS NOT REPORTED TO MICROLINE SURGICAL, INC. UNTIL (B)(6) 2023. SINCE THIS EVENT HAPPENED OVER A YEAR AGO, THE DEVICE THAT WAS USED IS NOT AVAILABLE FOR TESTING AND A FULL INVESTIGATION COULD NOT BE COMPLETED. HOWEVER, A CORRECTIVE ACTION FOR EVENTS RELATED TO A DETACHED HEAT SHRINK WAS CREATED IN MARCH OF 2023. THE CORRECTIVE ACTION SPECIFIES THAT THE WORK INSTRUCTIONS WOULD BE UPDATED TO CLARIFY THE HEAT SHRINK PROCESS, THE HEAT SHRINK OVEN PARAMETERS WOULD BE UPDATED FOR CLARITY, AND IT WOULD BE SPECIFIED THAT THE OVEN DOOR SHOULD NOT BE LEFT OPEN FOR MORE THAN 10 SECONDS. ALTHOUGH TESTING OF THE ACTUAL DEVICE CAN NOT BE DONE, THE FINAL RESULTS FOR THIS ADVERSE EVENT FALL UNDER THE CORRECTIVE ACTION THAT MICROLINE SURGICAL, INC. CURRENTLY HAS OPEN FOR SIMILAIR REPORTS (CAR-0171).

    Description of Event or Problem · 0

    DURING THE LAPAROSCOPY TECHNIQUE IN A INGUINAL HERNIA PROCEDURE, A PIECE OF THE PLASTIC COVER THAT COVERS THIS CLAMP REMOVED, REMAINING INSIDE THE PATIENT. THE ANESTHESIST OBSERVED A FOREIGN BODY ON THE SCREEN AND ALERTED THE SURGEONS WHO REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958884 RENEW 4 RACHETED HANDPIECE, 34CM MANUAL DETACHABLE SURGICAL INSTRUMENT GEI MICROLINE SURGICAL INC 3914 00811099010579

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention