BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 LARGE CAPACITY

    MDR report key: 1060008 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00708
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED AS IT HAS BEEN DISPOSED OF, THEREFORE, THE CAUSE OF THE BEND IS UNDETERMINED. THE APRIL 2008 15 MONTH COMPLAINT TREND REPORT FOR THE RADIAL JAW 3 BIOPSY FORCEP PRODUCT FAMILY INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW BIOPSY FORCEPS WAS GOING TO BE USED DURING A COLONOSCOPY IN A MALE PATIENT (AGE AND WEIGHT UNKNOWN) IN 2008. ACCORDING TO THE COMPLAINANT "THE END OF THE BIOPSY FORCEPS WERE BENT AND THEY COULD NOT OPEN OR CLOSE THE FORCEPS." THE PROCEDURE WAS COMPLETED WITH A SECOND RADIAL JAW, AND THERE ARE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 LARGE CAPACITY FCL BOSTON SCIENTIFIC CORPORATION M00515983 11389647

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK