BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI

    MDR report key: 20955431 · Received December 17, 2024

    Report

    Report Number
    3009495876-2024-00001
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BEILUN PLASTECH INC
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. NO HARM TO PATIENT OR COMPLICATIONS WERE REPORTED. THIS IS THE FIRST PRODUCT PROBLEM REPORTED WITH PMILK40 LOT NUMBER 002231004. ONLY ONE DEVICE FROM THE LOT OF 1000 IS AFFECTED. THERE HAS BEEN ONE SIMILAR REPORT FOR THIS DEVICE AS A WHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290649 PMI PMI ENDOSCOPIC DISSECTOR WITH KITTNER TIP GDI BEILUN PLASTECH INC PMILK40 002231004

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male