BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 2MM

    MDR report key: 1883081 · Received October 15, 2010

    Report

    Report Number
    2430952-2010-00056
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 15, 2010
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    DOCTOR HIT BONE, SLIDE PART OF INSTRUMENT BENT AND CAME OFF THE TRACK. NO PT INJURY RECORDED. ON (B)(6) 2010, CUSTOMER (OPERATING ROOM MATERIALS MANAGER) STATES VIA PHONE THAT THEY ARE UNABLE TO PROVIDE INFORMATION REGARDING THE SURGICAL PROCEDURE THAT THIS DEVICE WAS BEING USED FOR WHEN THE EVENT OCCURRED. PERSON WHO FILED THE COMPLAINT IS NO LONGER EMPLOYED THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 2MM ULTRA-COAT MDM

    Patients

    Seq Age Sex Outcome Treatment
    1