BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 2212903 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02731
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE NEEDLE WAS BENT. FUNCTIONALLY, THE JAWS OPENED, BUT FAILED TO CLOSE PROPERLY DUE TO THE BENT NEEDLE. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND CRIMPING WHICH WERE WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE NEEDLE WAS BENT. HOWEVER, THE EVALUATION FOUND THAT THE JAWS FAILED TO CLOSE PROPERLY DUE TO THIS ISSUE. THE BEND LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH AFFECTED THE DEVICE INTEGRITY AND LIMITED ITS PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    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 BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS NEEDLE BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE PRELIMINARY INVESTIGATION RESULTS; JAWS ARE UNABLE TO CLOSE.

    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 BIOPSY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS NEEDLE BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE PRELIMINARY INVESTIGATION RESULTS; JAWS ARE UNABLE TO CLOSE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1