BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORAS OR HEAD HOLDER - C-ARC

    MDR report key: 1789529 · Received August 5, 2010

    Report

    Report Number
    3004929307-2010-00001
    Event Type
    Other
    Date Received
    August 5, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    NORAS MRI PRODUCTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K071179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL: THE CASE WAS CHANGED TO OPEN CRANIOTOMY DURING THE SAME SURGERY, WITH SATISFACTORY CLINICAL OUTCOME. NEVERTHELESS, A RISK TO PT HEALTH COULD NOT BE EXCLUDED FOR THIS EVENT. ACCORDING TO THE PROVIDED INVESTIGATION VIDEOS OF THE DEVICE ON SITE, IT LOOKS LIKE THE INTERFACE FOR THE BRAINLAB REFERENCE STAR ON THE C-ARC OF THE HEAD HOLDER IS LOOSE. OBVIOUSLY THIS WAS NOT RECOGNIZED BY THE USER. INVESTIGATION RESULTS AND CONCLUSIONS CAN FIRST BE PROVIDED AFTER FAILURE ANALYSIS OF THE C-ARC INVOLVED. THE DEFECTIVE C-ARC HAS BEEN RETURNED TO NORAS FOR INVESTIGATION BUT DID NOT ARRIVE YET. CORRECTIVE AND PREVENTIVE ACTIONS: A NEW C-ARC WAS IMMEDIATELY SENT TO THE CUSTOMER AND MEANWHILE SUCCESSFULLY USED ON A CRANIOTOMY CASE. SINCE THE FAILURE ANALYSIS COULD NOT BE PERFORMED, DUE TO STILL MISSING C-ARC, WE CAN NOT DECIDE AT THIS TIME, WHAT CORRECTIVE AND PREVENTIVE ACTIONS, IF ANY, WOULD BE ADVISABLE.

    Description of Event or Problem · 1

    AS INFORMED BRAINLAB (B)(4), AN ATTEMPTED INTRACRANIAL BIOPSY SUPPORTED BY THE BRAINLAB NAVIGATION SYSTEM WAS UNSUCCESSFUL AFTER 5 ATTEMPTS. THE USER VERIFIED WITH AN MRI SCAN THAT THE ACTUAL APPLIED TRAJECTORY DIFFERED FROM THE PLANNED, INTENDED TRAJECTORY. THE NORAS OPERATING ROOM HEAD HOLDER - C-ARC WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORAS OR HEAD HOLDER - C-ARC OR HEAD HOLDER - HBL HBL NORAS MRI PRODUCTS GMBH SI7004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1