BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLSEN ENDOSCOPIC CHOLANGIOGRAPHY SET

    MDR report key: 39546 · Received September 26, 1996

    Report

    Report Number
    1820334-1996-00015
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    August 30, 1996
    Report Date
    August 30, 1996
    Manufacturer
    COOK, INC.
    Product Code
    GBZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING UTILIZED FOR A PERCUTANEOUS CHOLECYSTECTOMY PROCEDURE. THE PHYSICIAN WAS USING GRASPING FORCEPS TO ADVANCE THE CATHETER. UPON ATTEMPTED REMOVAL OF THE CATHETER, THE ACORN TIP SEPARATED AND REMAINED IN THE ABDOMINAL WALL. THE SEPARATED SEGMENT WAS LATER RETRIEVED DURING AN UNRELATED EXPLORATORY LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN ENDOSCOPIC CHOLANGIOGRAPHY SET CHOLANGIOGRAPHY SET GBZ COOK, INC. NA 639044

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention