BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 SINGLE-USE BIOPSY FORCEP

    MDR report key: 1052542 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00517
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVALUATION IS NOT COMPLETE. THEREFORE, THE CAUSE OF THE REPORTED OBSERVATION HAS NOT BEEN DETERMINED. THE APRIL 2008 15-MONTH RADIAL JAW BIOPSY FORCEP PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A RADIAL JAW 4 BIOPSY FORCEP DEVICE WAS USED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE (FEMALE PATIENT, WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE BIOPSY SAMPLE WAS SUCCESSFULLY ACQUIRED, AND THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT WHILE THE BIOPSY SAMPLE WAS BEING TRANSFERRED FROM THE FORCEP INTO A TISSUE CUP, "AN IRREGULARITY" WAS NOTED ON ONE OF THE PULL WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 SINGLE-USE BIOPSY FORCEP KNW BOSTON SCIENTIFIC CORPORATION M00513322 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR