BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMERICAN CATHETER BIOPSY FORCEP

    MDR report key: 307455 · Received November 29, 2000

    Report

    Report Number
    1287321-2000-00001
    Event Type
    Other
    Date Received
    November 29, 2000
    Date of Event
    April 23, 1998
    Report Date
    April 29, 1998
    Manufacturer
    AMERICAN CATHETER CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER INSERTED THROUGH ENDOSCOPE TO TAKE GASTRIC BIOPSY. WHEN HANDLE DEPRESSED TO OPEN TIP, PINGING SOUND HEARD. METAL TIP FELL OFF CATHETER END ONTO MUCOSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN CATHETER BIOPSY FORCEP BIOPSY FORCEP FCL AMERICAN CATHETER CORPORATION 7200 803611

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention