BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1935569 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05335
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WASHER TAIL WAS BENT OUT OF THE CLEVIS. THE PULL WIRES OF THE DEVICE WERE INTACT AND WERE NOT BROKEN. MEASUREMENTS WERE TAKEN OF THE PULL WIRE CURVES; ONE OF THE TWO CURVES WAS OUT OF SPECIFICATION. ADDITIONALLY, NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN DESIGN SPECIFICATION. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN AND CLOSE NORMALLY CONSIDERING THE BENT WASHER TAIL. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT. THE EVALUATION FOUND THAT THE PULL WIRE WAS NOT BROKEN, BUT THE WASHER TAIL WAS BENT AND APPEARED AS IF A WIRE WAS BROKEN. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT EXIST TO LIMIT PRODUCT PERFORMANCE ISSUES. ADDITIONALLY, THE DFU INDICATES THAT THE DEVICE SHOULD BE INSPECTED PRIOR TO USE AND THAT EXCESSIVE FORCE SHOULD BE AVOIDED WHEN HANDLING THE DEVICE. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WAS ADVANCED THROUGH THE SCOPE WITHOUT ISSUE. HOWEVER, AS A BIOPSY WAS BEING TAKEN, THE WIRE CAME OFF THE JAWS AND CONTACTED THE WORKING CHANNEL OF THE SCOPE. THE ACCOUNT REPORTED THAT NO PART OF THE WIRE DETACHED OR FELL INSIDE THE PATIENT. ADDITIONALLY, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513322 0013738615

    Patients

    Seq Age Sex Outcome Treatment
    1