BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID 3 PRONG GRASPER FOR RETRIEVAL OF STONES

    MDR report key: 3606675 · Received January 24, 2014

    Report

    Report Number
    2951238-2014-00029
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    September 17, 2013
    Report Date
    January 8, 2014
    Manufacturer
    GYRUS ACMI INC
    Product Code
    JEK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, AS IT HAS BEEN DISCARDED BY THE USER FACILITY AFTER THE PROCEDURE. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL AND RELEVANT INFORMATION BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH FORM FROM THE USER FACILITY, WHICH STATES THAT DURING A PERCUTANEOUS NEPHROSTOLITHOTOMY OF A LARGE AND CALCIFIED STONE, THE PRONGS SPONTANEOUSLY BROKE FROM THE GRASPER. THE SURGEON WAS USING THE GRASPER FORCEPS WHILE DISSOLVING THE STONE WHILE A LASER WHEN THE PRONGS BROKE. THE PIECES WERE RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH AN UNIDENTIFIED DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55807 RIGID 3 PRONG GRASPER FOR RETRIEVAL OF STONES RIGID 3 PRONG GRASPING FORCEPS JEK GYRUS ACMI INC RPG-437 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LASER: MODEL AND MFR UNK