BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOMYOCARDIAL BIOPSY FORCEPS

    MDR report key: 1700213 · Received May 9, 2010

    Report

    Report Number
    1700213
    Event Type
    Malfunction
    Date Received
    May 9, 2010
    Date of Event
    February 23, 2010
    Report Date
    May 9, 2010
    Manufacturer
    CERES MEDICAL SYSTEMS, L.L.C.
    Product Code
    DWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOPTOME CATHETER FORCEPS FAILED TO OBTAIN AN ENDOMYOCARDIAL BIOPSY SAMPLE. A SECOND BIOPTOME CATHETER WAS USED WHICH WORKED PERFECTLY. THE PATIENT HAD NO COMPLICATIONS DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOMYOCARDIAL BIOPSY FORCEPS ENDOMYOCARDIAL BIOPSY FORCEPS DWZ CERES MEDICAL SYSTEMS, L.L.C. * 01418531

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR