BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2250051-2009-00087

    MDR report key: 1356290 · Received March 5, 2009

    Report

    Report Number
    2250051-2009-00087
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Product Code
    JTC
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS BEEN INVESTIGATED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT, INSPECTED X-ARM ASSEMBLY AND FOUND BENT TIP CLAMPS. FSE REPLACED THE TIP CLAMPS AND CLEANED THE SLEEVES. THE INSTRUMENT WAS TESTED WITHOUT FURTHER PROBLEM AND WAS RETURNED TO EXPECTED OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JTC

    Patients

    Seq Age Sex Outcome Treatment
    1