BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATION SYSTEM II - CART

    MDR report key: 5391579 · Received January 26, 2016

    Report

    Report Number
    0001811755-2016-00094
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    January 13, 2016
    Report Date
    January 13, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT ONE OF THE SCREWS LOCATED WITHIN THE WHEEL BROKE, LEAVING THE CART WITH ONLY 3 SUPPORTING WHEELS WAS CONFIRMED VISUAL INSPECTION. THE WHEEL WAS REPLACED AND REPAIRED AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A NURSE WAS TRANSPORTING A NAVIGATION SYSTEM II CART OUT OF THE OPERATING THEATRE, THE CASTOR BROKE OFF OF THE CART. THE NURSE ATTEMPTED TO SUPPORT THE WEIGHT OF THE CART IN ORDER TO AVOID THE CART TIPPING OVER. THE NURSE REPORTED LOCALIZED PAIN ON THE RIGHT SIDE OF HER BACK, RUNNING FROM HER SHOULDER BLADE TO THE UPPER PORTION OF HER LEG, FOR WHICH SHE WAS TREATED WITH PAINKILLERS, PARACETAMOL + DICLOFENIC, BUT CONTINUES TO EXPERIENCE PAIN IN HER BACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A NURSE WAS TRANSPORTING A NAVIGATION SYSTEM II CART OUT OF THE OPERATING THEATRE, THE CASTOR BROKE OFF OF THE CART. THE NURSE ATTEMPTED TO SUPPORT THE WEIGHT OF THE CART IN ORDER TO AVOID THE CART TIPPING OVER. THE NURSE REPORTED LOCALIZED PAIN ON THE RIGHT SIDE OF HER BACK, RUNNING FROM HER SHOULDER BLADE TO THE UPPER PORTION OF HER LEG, FOR WHICH SHE WAS TREATED WITH PAINKILLERS, PARACETAMOL + DICLOFENIC, BUT CONTINUES TO EXPERIENCE PAIN IN HER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49078 NAVIGATION SYSTEM II - CART NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other