BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAPHY INSTRUMENT

    MDR report key: 45686 · Received October 21, 1996

    Report

    Report Number
    2522397-1996-00015
    Event Type
    Malfunction
    Date Received
    October 21, 1996
    Date of Event
    August 30, 1996
    Report Date
    October 21, 1996
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED IMMEDIATELY POST-LAPAROSCOPIC CHOLECYSTECTOMY THAT THE TIP OF THE LAPAROSCOPIC GRASPER HAD BROKEN OFF. PT X-RAYED AND X-RAY SHOWED FAINTLY DECERNABLE SIMILARLY SHAPED SHADOW. AT THE TIME A DECISION WAS REACHED NOT TO RETRIEVE THIS TIP OF THE LAPAROSCOPIC GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLANGIOGRAPHY INSTRUMENT CHOLANGIOGRAM CATHETER HOLDER GCJ CABOT MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR