BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPER, HYSTEROSCOPY

    MDR report key: 2032624 · Received March 16, 2011

    Report

    Report Number
    2032624
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    September 17, 2010
    Report Date
    September 21, 2010
    Manufacturer
    KARL STORZ
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    ONE OF THE SMALL JAWS LOCATED AT THE END OF THE GRASPER FELL OFF DURING SURGERY. IT WAS IMMEDIATELY REMOVED. IT APPEARS AS TO HAVE HAD A SMALL MICROSCOPIC FRACTURE THAT CAUSED THE BREAK. BIOMED AND RISK ASSESSED THE DEVICE. THE HANDLE WORKED APPROPRIATELY BY OPENING AND CLOSING THE JAWS. I DO NOT HAVE THE DEVICE IN OUR LOCK UP SO I AM UNABLE TO DETERMINE IF IT WAS SENT BACK TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASPER, HYSTEROSCOPY GRASPER FOR BIOPSY COLLECTION FCL KARL STORZ UHW EB 01

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR