BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 2031580 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00894
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE (B)(6). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE NEEDLE TO BE BENT. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN HOWEVER, THE BENT NEEDLE DID NOT ALLOW PROPER JAW CLOSURE. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. IT COULD NOT BE CONFIRMED IF THE BENT NEEDLE LED TO THE REPORTED EVENT. HOWEVER, THE EVALUATION FOUND THAT THE JAWS WOULD NOT CLOSE COMPLETELY DUE TO THE THIS CONDITION. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE WAS LIKELY APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING A COLON BIOPSY PROCEDURE PERFORMED ON (B)(4), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, TWO BIOPSY SPECIMENS WERE SUCCESSFULLY RETRIEVED FROM THE COLON. HOWEVER, AFTER PERFORMING A THIRD BIOPSY, NO TISSUE WAS WITHIN THE JAWS. NO DEVICE DAMAGE WAS VISIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE. REPORTEDLY, THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; JAWS WON'T CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515372 0013772892

    Patients

    Seq Age Sex Outcome Treatment
    1