BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2151869 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02286
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18 YEARS. 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).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE JAWS WERE MISALIGNED. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN PROPERLY, HOWEVER, THEY COULD NOT CLOSE COMPLETELY. THE DEVICE WAS DISASSEMBLED AND IT WAS FOUND THAT ONE JAW WAS BENT AT THE TANG. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE JAWS WERE NOT ALIGNED AND DID NOT CLOSE COMPLETELY. 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. 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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DEVICE WAS EXAMINED BEFORE USE AND IT WAS NOTED THAT THE JAWS WERE NOT ALIGNED AND DID NOT CLOSE COMPLETELY. HOWEVER, THE DEVICE WAS USED TO SUCCESSFULLY OBTAINED MORE THAN 4 BIOPSY SPECIMENS AND REMOVED POLYPS FROM THE PATIENT'S RECTUM. ADDITIONALLY, IT WAS REPORTED THAT NORMAL BLEEDING OCCURED WITH NO REQUIRED INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

    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 COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DEVICE WAS EXAMINED BEFORE USE AND IT WAS NOTED THAT THE JAWS WERE NOT ALIGNED AND DID NOT CLOSE COMPLETELY. HOWEVER, THE DEVICE WAS USED TO SUCCESSFULLY OBTAINED MORE THAN 4 BIOPSY SPECIMENS AND REMOVED POLYPS FROM THE PATIENT'S RECTUM. ADDITIONALLY, IT WAS REPORTED THAT NORMAL BLEEDING OCCURED WITH NO REQUIRED INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513331 14130706

    Patients

    Seq Age Sex Outcome Treatment
    1