BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE RETRIEVAL GRASPING FORCEPS

    MDR report key: 1172913 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04732
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    A TALON 3 PRONG STONE RETRIEVAL GRASPING FORCEP WAS USED DURING A URETEROSCOPY PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, ONE OF THE TALONS WOULD NOT OPEN AND CLOSE PROPERLY. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE RETRIEVAL GRASPING FORCEPS FFL BOSTON SCIENTIFIC CORPORATION M0063701140 8678163

    Patients

    Seq Age Sex Outcome Treatment
    1