BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 2.2 MM X 50 CM

    MDR report key: 2935597 · Received January 23, 2013

    Report

    Report Number
    MW5028780
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 23, 2013
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS EMPLOYED ENDOSCOPICALLY FOR PANCREATIC LOBULE BIOPSY. THE DEVICE SNAPPED DURING THE PROCEDURE WHEN THE PROVIDER ATTEMPTED TO CLOSE THE CLAMP/TEETH. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33213 JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 2.2 MM X 50 CM BIOPSY FORCEP DWZ ARGON MEDICAL DEVICES, INC. A32965

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR