BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW

    MDR report key: 4216694 · Received October 15, 2014

    Report

    Report Number
    4216694
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    BWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROXIMAL ESOPHAGEAL BIOPSY, RADIAL JAW FORCEP (LOT #16995416) (BOSTON SCIENTIFIC) A PIECE OF METAL CAME OFF DURING BIOPSY AND WAS VISIBLE IN THE ESOPHAGUS. PIECE OF METAL WAS ABLE TO BE REMOVED WITH THE FORCEP AND NO VISIBLE INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656260 RADIAL JAW FORCEPS BWH BOSTON SCIENTIFIC CORPORATION * 16995416

    Patients

    Seq Age Sex Outcome Treatment
    1 *