BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI ENDOSCOPIC DISSECTOR INSTRUMENT

    MDR report key: 20622364 · Received November 5, 2024

    Report

    Report Number
    MW5162223
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 1, 2024
    Manufacturer
    PROGRESSIVE MEDICAL INC
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A ROBOTIC LEFT RETROPERITONEAL PARTIAL NEPHRECTOMY CASE, AN ENDOSCOPIC PEANUT'S COTTON TIP DETACHED FROM THE HANDLE WHILE INSIDE THE PATIENT THROUGH THE TROCAR. THE SURGEON WAS INFORMED AND HE KNEW AS WELL SINCE HE WAS THE ONE MANIPULATING THE ENDOSCOPIC PEANUT AND SAW IT FALL OFF. HE IMMEDIATELY PICKED UP THE COTTON TIP AND TOOK IT OUT IN ONE PIECE. HE ALSO CONDUCTED A COMPREHENSIVE SWEEP OF THE ABDOMINAL CAVITY. THE SURGEON DETERMINED THAT NO FURTHER EXAMINATION OR INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943242 PMI ENDOSCOPIC DISSECTOR INSTRUMENT DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI PROGRESSIVE MEDICAL INC PMILK40 002231004

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male