BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2221048 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02927
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 STANDARD CAPACITY WAS USED DURING A COLON BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER TAKING A BIOPSY SAMPLE AND WITHDRAWING THE DEVICE THROUGH THE SCOPE, THE SAMPLE WAS LOST. IT WAS THEN NOTICED THAT THE JAWS WERE NOT CLOSING SHUT ALL THE WAY, BUT NO DEVICE DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH THE SAME RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. REPORTEDLY THE DEVICE WAS INSPECTED VISUALLY PRIOR TO USE. 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 M00513402 0014166416

    Patients

    Seq Age Sex Outcome Treatment
    1