BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEP W/NEEDLE

    MDR report key: 1052728 · Received May 23, 2008

    Report

    Report Number
    3005099803-2008-00538
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED BY THE USER FAICLITY; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED, IT HAS NOT BEEN RECIEVED FOR EVALUATION. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE APRIL 2008 25-MONTH RADIAL JAW BIOPSY FORCEP PRODUCT FAMILY COMPLAINT TREND, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WHILE OPENING THE PACKAGE OF A RADIAL JAW 3 BIOPSY FORCEP DEVICE, "THE RADIAL JAW WAS BROKEN IN THE PACKAGING. THE THREAD COMES OUT OF THE TIP." ON MAY 14, 2008, FOLLOW UP INFORMATION WAS ASCERTAINED WHICH REVEALED THAT "...THE WIRES WERE STICKING OUT TO THE SIDE 1 TO 2 MM." THE DEVICE WAS NOT USED IN A PROCEDURE: THEREFORE, THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEP W/NEEDLE KNW BOSTON SCIENTIFIC CORPORATION M00515370 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK