BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIL BLUNT TIP 12 100MM

    MDR report key: 20687309 · Received November 13, 2024

    Report

    Report Number
    MW5162523
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 11, 2024
    Manufacturer
    APPLIED MEDICAL DISTRIBUTION CENTER
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY A 12 MM TROCAR WAS INSERTED INTO THE ABDOMEN TO GAIN ACCESS. WHILE REMOVING A LAPAROSCOPIC INSTRUMENT FROM THE TROCAR, THE TROCAR FELL APART. THE TROCAR WAS REMOVED FROM THE PATIENT AND ALL PARTS WERE ACCOUNTED FOR. THE TROCAR AND PACKAGING WERE COLLECTED AND TURNED IN FOR INSPECTION. PER THE SURGEON THERE WAS NO PATIENT HARM DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169153 KIL BLUNT TIP 12 100MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL DISTRIBUTION CENTER 1525242

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female