BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC BK PROBE L12C4F

    MDR report key: 15969966 · Received December 12, 2022

    Report

    Report Number
    MW5113739
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BK MEDICAL APS
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN INSERTING THE BK MEDICAL LAPAROSCOPIC PROBE THE SHEATH COVERING THE FLEXIBLE TIP TORE AND A PIECE FELL IN PATIENT ABDOMEN. THIS PARTICULAR STYLE PROBE HAS HAD THIS SAME INCIDENT HAPPEN FOUR TIMES NOW. THE SHEATH COVERING IS EITHER TOO THIN OR NOT PLIABLE ENOUGH TO HANDLE THE INSERTION THROUGH A TROCAR. THE DIAMETER IS 8MM AND THE TROCAR WAS 11 YET IT STILL TORE UPON INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050162 LAPAROSCOPIC BK PROBE L12C4F TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BK MEDICAL APS 9066

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other