BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 19330449 · Received May 15, 2024

    Report

    Report Number
    MW5154969
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 13, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAM. DURING THE PROCEDURE, THE SURGEON PLACED A HASSON TROCAR INTO THE PATIENTS ABDOMEN END ATTEMPTED TO BLOW UP THE BALLOON TO HOLD THE TROCAR IN PLACE TO FIND THE BALLOON HAD A HOLE IN IT. THE TROCAR WAS REMOVED FROM THE PATIENT'S ABDOMEN AND ANOTHER TROCAR WAS PLACED. PROCEDURE WAS SUCCESSFULLY COMPLETE AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530709 KII BALLOON BLUNT TIP SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. C0R47 1508905

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention