BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1872982 · Received October 18, 2010

    Report

    Report Number
    3005099803-2010-04255
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A KINK IN THE SHEATH APPROXIMATELY 50CM FROM THE PROXIMAL END, AND THE FORCEPS NEEDLE WAS BENT. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND WELDING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY THE DEVICE JAWS WOULD OPEN HOWEVER, THE BENT NEEDLE DID NOT ALLOW PROPER JAW CLOSURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; SHEATH BENT. HOWEVER, DURING DEVICE EVALUATION IT WAS FOUND THAT THE FORCEPS NEEDLE WAS BENT. THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGE TO THE RETURNED DEVICE IS DUE TO HANDLING BY THE END USER. 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)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER TAKING THE DEVICE OUT OF THE PACKAGING A BEND IN THE SHEATH WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; NEEDLE BENT.

    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 M00513331 0013440696

    Patients

    Seq Age Sex Outcome Treatment
    1