BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1924013 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05097
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE PASSED THE FUNCTIONAL INSPECTION. 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. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AS THE DEVICE WAS UNPACKED, A WIRE WAS NOTED TO BE STICKING OUT OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 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 OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW BIOPSY FORCEPS DEVICE WAS USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AS THE DEVICE WAS UNPACKED, A WIRE WAS NOTED TO BE STICKING OUT OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 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 OKAY.

    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 M00513321 0013540513

    Patients

    Seq Age Sex Outcome Treatment
    1