BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8665082 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02887
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: ORIGINAL PROBLEM WAS SCU FUSES FAIL 2 TIMES. SECOND PROBLEM WAS IMPORTATION OF CRANIAL PATIENT FROM OARM.(3.0.1 KNOWN PROBLEMS); RESOLVED: YES SOFTWARE: FAIL; FAILURES: IMPORT EXAM; SUMMARY: ORIGINAL PROBLEM WAS SCU FUSES FAIL 2 TIMES. SECOND PROBLEM WAS IMPORTATION OF CRANIAL PATIENT FROM OARM.(3.0.1 KNOWN PROBLEMS); MNAV ACTION/RESOLUTION: DEFINITIVE REPLACEMENT OF THE FOLLOW SPARE PARTS: - 9733582 LOT150127 BY LOT161221 - 9733575, LOT150720 BY LOT120820 - 9733437, S/N: (B)(4) - 9735586 CRANIAL 3.0.2. SUMMARY: CAMERA LED OFF. SCU LED OFF. FUSES UN SCU OPEN. THIS FUSES WAS REPLACED AND ALL SYSTEM WORKED AGAIN. MNAV ACTION/RESOLUTION: 2 FUSES 2A 250V INSIDE THE SCU (9733438) WERE REPLACED. THIS ALLOWED TO USE THE EQUIPMENT TEMPORARILY. IS RECOMMENDED THE REPLACEMENT OF SCU, PSU AND CABLE. OTHER RELEVANT DEVICE(S) ARE: MODEL: 9733581. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE POSITIONING SENSOR UNIT (PSU) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PSU WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE PSU TO POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CABLE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE EXTERNAL PSU TO SCU CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CABLE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SCU WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE SCU WOULD NOT POWER ON. THE LINE FILTER FUSES WERE NOTED TO HAVE ONE OPEN FUSE. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WILL NOT POWER ON. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457929 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1