BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTOR SERVICE MODULE 120V

    MDR report key: 1879832 · Received October 13, 2010

    Report

    Report Number
    8010219-2010-00009
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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 UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE SELECTOR SERVICE MODULE WAS USED FOR A CRANIOTOMY ON A PATIENT (AGE AND GENDER UNSPECIFIED). THE POWER OF THE PRODUCT WAS REPORTED TO NOT WORK. MULTIPLE HAND PIECES HAD BEEN USED AND POWER WAS STILL NOT WORKING. THERE WAS NO ALARM INDICATING A POWER FAILURE. THERE WAS NO PATIENT INJURY BUT THE PRODUCT PROBLEM DID CAUSE A TWENTY MINUTE DELAY IN SURGERY TO LOCATE AND SET UP A NEW MACHINE. NO OTHER INFORMATION WAS PROVIDED. CROSS REFERENCED TO MANUFACTURER REPORT NUMBER 8010219-2010-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR SERVICE MODULE 120V NA LFL INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1