BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1213836 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05416
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DHR (DEVICE HISTORY RECORD) REVIEW PERFORMED, AND NO DEVIATION WAS FOUND; RELATED WITH THE EVENT REPORTED. NO OTHER COMPLAINT HAVE BEEN REPORTED FOR THE LOT NUMBER. THE UNIT WAS NOT RETURNED BY THE CUSTOMER; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. LABELING REVIEW WAS PERFORMED DFU (DIRECTIONS FOR USE) INDICATE: ENDOSCOPY SHOULD BE PERFORMED ONLY BY PERSONS HAVING ADEQUATE EXPERIENCE AND TRAINING. THE PACKAGING AND THE DEVICE SHOULD BE INSPECTED PRIOR TO USE. DO NOT USE THE DEVICE IF THE PRODUCT OR PACKAGING IS DAMAGED. IF THE DEVICE FAILS TO OPERATE PROPERLY IN ANY WAY OR SHOWS ANY SIGN OF DAMAGE, DO NOT USE IT. MAINTAINING THE FORCEPS IN A CLOSED POSITION, SLOWLY WITHDRAW THE FORCEPS THROUGH THE ENDOSCOPE. IF FOR ANY REASON THE BIOPSY JAWS FAIL TO CLOSE PROPERLY OR COMPLETELY, DO NOT TRY TO WITHDRAW A PARTIALLY OPEN FORCEPS THROUGH A SCOPE. PULL THE FORCEPS BACK TO THE CHANNEL OPENING AND THEN WITHDRAW THE SCOPE AND FORCEPS TOGETHER. CAUTION: APPLICATION OF EXCESSIVE FORCE TO THE FORCEPS MAY DAMAGE THE DEVICE. THE FORCEPS SHOULD BE HELD WITH THE INDEX FINGER AND MIDDLE FINGER COMFORTABLY RESTING ON THE SPOOL LEDGE AND THE THUMB IN THE LOOP. WHEN OTHER METHODS OF OPERATION ARE USED, SUCH AS PUSHING ON THE THUMB LOOP WITH THE PALM OF ONE'S HAND, EXCESSIVE FORCE MAY DAMAGE THE JAWS. IT IS IMPORTANT TO FOLLOW DFU INSTRUCTIONS SINCE DFU HELPS TO ENSURE THE CORRECT USE OF THE DEVICE. THE DETERMINATION OF A ROOT CAUSE MAY NOT BE COMPLETED WITHOUT ANALYSIS OF THE DEVICE INVOLVED, THEREFORE THE ROOT CAUSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A BIOPSY PROCEDURE, THE RADIAL JAW 3 BIOPSY FORCEPS JAWS DID NOT OPEN AND CLOSE CORRECTLY. WHEN THEY REMOVED THE DEVICE FROM THE PT, THEY DISCOVERED THAT THE FORCEPS WERE BROKEN. ATTEMPTS BY THE MFR TO OBTAIN ADDITIONAL INFO AS TO WHAT PARTICULAR PART OF THE DEVICE WAS BROKEN HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515231 0007896678

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK