BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RABINOV SIALOGRAPHY SET

    MDR report key: 83291 · Received July 3, 1996

    Report

    Report Number
    83291
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    April 29, 1996
    Report Date
    May 10, 1996
    Manufacturer
    COOK INCORPORATED
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHOLANGIOCATH WAS USED FOR A CHOLANGIOGRAM DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE METAL TIP SEPARATED FROM THE CATHETER WHILE IN THE DUCT. THE METAL TIP WAS RETRIEVED WITHOUT DIFFICULTY. DEVICE HAS BEEN RETURNED EXCEPT FOR METAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RABINOV SIALOGRAPHY SET CHOLANGIOGRAM CATHETER GBZ COOK INCORPORATED * 614210

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR