BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8706099 · Received June 17, 2019

    Report

    Report Number
    1723170-2019-03481
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    October 23, 2017
    Report Date
    June 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CART 9733858 S7 ASSEMBLED STAFF 220V (SERIAL #: (B)(4)) FOUND HARDWARE FAILURE, AS THERE WAS A DAMAGED CAMERA/SCU. THE SCU AND CAMERA WOULD HAVE AN ERROR SOUND. AFTER A CHECK, IT WAS FOUND THAT THE SCU DID NOT WORK. THE MACHINE WORKED NORMALLY AFTER REPLACING SCU PARTS. PRODUCT EVENT SUMMARY #S7 SCU & CAMERA ALWAYS SHOW ERROR SOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SCU AND CAMERA ALWAYS "SHOW ERROR SOUND." IT WAS UPDATED THAT THE SCU DID NOT FUNCTION AS INTENDED AND THE SCU WAS REPLACED, AT WHICH TIME THE SYSTEM FUNCTIONED AS INTENDED. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498408 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1