BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN CATHETER CORP

    MDR report key: 539344 · Received August 13, 2004

    Report

    Report Number
    539344
    Event Type
    Injury
    Date Received
    August 13, 2004
    Date of Event
    August 12, 2004
    Report Date
    August 12, 2004
    Manufacturer
    AMERICAN CATHETER CORP
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOT BIOPSY FORCEPS WAS INSERTED INTO THE COLONOSCOPE TO OBTAIN A BIOPSY. THE JAWS OF THE FORCEPS WOULD NOT CLOSE. THE HANDLE FELL APART IN THE TECH'S HAND. THE BIOPSY FORCEPS COULD NOT BE PULLED THROUGH THE SCOPE. THE COLONOSCOPE THEN NEEDED TO BE REMOVED FROM PT. THE TIP OF THE FORCEPS WAS CUT AND REMOVED FROM SCOPE. THE SCOPE THEN HAD TO BE REINSERTED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN CATHETER CORP HOT BX FORCEP LDD AMERICAN CATHETER CORP PRODUCT# 7501 4050508

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention