BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1324258 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02052
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    March 18, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL/MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WAS PERFORMED AND REVEALED THE FOLLOWING: (1) ONE OF THE TWO PULL WIRES WAS DETACHED FROM THE CUTTERS, (2) THE Z-BEND SECTION OF THE PULL WIRE WAS BROKEN, AND (3) THE NEEDLE TAIL WAS BENT. THIS CUSTOMER COMPLAINT WAS CONFIRMED, THE ROOT CAUSE OF THIS PROBLEM COULD NOT BE DEFINITIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A RADICAL JAW 3 BIOPSY FORCEPS DEVICE WAS BEING PREPARED FOR USE THE DAY PRIOR (PATIENT AGE, GENDER AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, "PRIOR TO USE, THEY WERE UNABLE TO OPEN THE CUP AND THE WIRE WAS FOUND DETACHED." THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 RADIAL JAW 3 BIOPSY FORCEPS BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION-COSTA RICA M00515791 0011312916

    Patients

    Seq Age Sex Outcome Treatment
    1