BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSA BRAIN

    MDR report key: 8616721 · Received May 16, 2019

    Report

    Report Number
    3009185973-2019-00183
    Event Type
    Death
    Date Received
    May 16, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 16, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K172444
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI# : (B)(4). REPORTEDLY, UPON THE SEEG SURGERY PERFORMED ON (B)(6) 2019 THE PATIENT PASSED AWAY FROM A HEMORRHAGE. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A COMPLETE MAINTENANCE WITH APPLICATIVE AND ACCURACY TESTS WAS PERFORMED ON 31-JAN-2019 AND THE DEVICE WAS CONFORM, ALL TESTS WERE PASSED. ANALYSIS OF AVAILABLE INFORMATION AND DATA LOGS WAS PERFORMED. TECHNICAL INVESTIGATION WAS NOT CONCLUSIVE AT THIS POINT, AND THE ROOT CAUSE OF THE HEMORRHAGE REMAINS UNKNOWN. HOWEVER, MULTIPLE FACTORS WERE IDENTIFIED THAT MIGHT HAVE IMPACTED THE OUTCOME OF THE SURGERY: THE UNUSUAL CURVATURE OF SOME OF THE IMPLANTED ELECTRODES. AN UNDETECTED MOVEMENT OF THE HEAD. THE REGISTRATION METHOD AND ITS QUALITY (NON VERIFIABLE AS ROSANNA LOG FILES AND VERIFICATION SCREEN-SHOTS ARE NOT AVAILABLE FOR ANALYSIS). THE IMAGE FUSION QUALITY (AUTOMATIC FUSIONS HAVE MOST PROBABLY NOT BEEN MANUALLY ADJUSTED). NONE OF THESE HYPOTHESES COULD BE CONFIRMED WITH AVAILABLE INFORMATION. THE ROOT CAUSE OF THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    SURGEON REPORTED ON (B)(6) THAT A PATIENT THAT HAD A SURGERY ON (B)(6) 2019 WITH ROSA DEVICE THE WEEK BEFORE PASSED AWAY FROM A BLEED. THE SURGEON SAID THAT THE ROSA ACCURACY WAS GOOD, AND DIDN'T BELIEVE IT CONTRIBUTED TO THE DEATH. THE PATIENT DID EAT THE MORNING OF THE CASE, CAUSING THE CASE TO BE DELAYED. THE TWO CT MACHINES AT THE HOSPITAL WERE OUT THE MORNING OF THE CASE, SO THE PATIENT WENT TO ANOTHER SITE TO HAVE A CT MORNING OF THE CASE. THE PATIENT WAS AWAKE DURING THE CT. ANESTHETIST REPORTED THERE MAY HAVE BEEN A BIG DIFFERENCE IN CO2 CAUSING SWELLING, AFTER ANESTHESIA. THE SURGEON ALSO ADD THAT THE PATIENT HAD LOTS OF BRAIN SWELLING AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409916 ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA BRAIN 3.0.0.21

    Patients

    Seq Age Sex Outcome Treatment
    1 Death