BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWZ

    MDR report key: 1010532 · Received February 18, 2008

    Report

    Report Number
    1010532
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT VENTRICULAR BIOPSY, A PIECE OF TISSUE BECAME ENTANGLED AROUND THE ARGON MEDICAL FORCEPS, WHERE THE SILVER FORCEPS MEETS THE BLUE COATING/SHEATHING. THIS AREA WAS NOT SEALED SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAWZ FORCEPS, BIOPSY KNW ARGON MEDICAL DEVICES, INC. * 070745

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR NO OTHER THERAPIES| NO OTHER THERAPIES