BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3

    MDR report key: 2559528 · Received April 27, 2012

    Report

    Report Number
    2559528
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    BWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE IT WAS NOTED THAT THE JAWS OF THE FORCEPS WERE SPRUNG WHILE REMOVING A SPECIMEN FROM THE DEVICE. ALL PARTS OF THE DEVICE WERE PRESENT, BUT THE JAWS WOULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 FORCEPS, BIOPSY BWH BOSTON SCIENTIFIC * 14819365

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR