BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2001107 · Received February 24, 2011

    Report

    Report Number
    3005099803-2011-00491
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    February 3, 2011
    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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WASHER TAIL WAS BENT AND PROTRUDING OUT OF THE CLEVIS. ADDITIONALLY, NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN AND CLOSE NORMALLY CONSIDERING THE BENT WASHER TAIL. MEASUREMENTS WERE TAKEN OF THE PULL WIRE CURVES AND IT WAS DETERMINED THAT ONE WAS OUT OF SPECIFICATION AND COULD HAVE CAUSED THE BENDING OF THE WASHER TAIL. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT SINCE THE RETURNED DEVICE VISUALLY REFLECTS THE REPORTED ISSUE. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED. THEREFORE THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE, HOWEVER, AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. 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 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED DURING (B)(6) 2010.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER TAKING A ROUTINE BIOPSY IT WAS NOTICED THAT ONE OF THE WIRES THAT FUNCTIONS THE JAWS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED, AND THERE WAS NO NOTICEABLE RESISTANCE FELT WHILE INSERTING OR REMOVING THE DEVICE THROUGH THE SCOPE.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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED DURING (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER TAKING A ROUTINE BIOPSY IT WAS NOTICED THAT ONE OF THE WIRES THAT FUNCTIONS THE JAWS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS JUMBO CAPACITY DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED, AND THERE WAS NO NOTICEABLE RESISTANCE FELT WHILE INSERTING OR REMOVING THE DEVICE THROUGH THE SCOPE. 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 M00513363 0013718684

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR