BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 15083466 · Received July 22, 2022

    Report

    Report Number
    3009185973-2022-00035
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 30, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS AND PATIENT FILES HAS BEEN PERFORMED AND CONCLUDED THAT THE INACCURACY OF ELECTRODES PLACEMENT REGARDING THE REGISTERED EXAM IS CONFIRMED ON TEMPORAL ELECTRODES. IT WAS FOUND THAT THE AUTOMATIC REGISTRATION PROVIDED CORRECT RESULTS BUT WAS NOT OPTIMAL. AS THE REGISTRATION IS BASED ON THE SURFACE MATCHING, ALTHOUGH THE PATTERNS ARE CLEAR AND VISIBLE, THEY DO NOT COVER A SUFFICIENT SURFACE TO PROVIDE AN OPTIMAL REGISTRATION ACCURACY. THAT PRACTICE COULD BE A FACTOR OF THE UNEXPECTED INACCURACIES OBSERVED ON THE TEMPORAL ELECTRODES AS THEY ARE SLIGHTLY OVER THE 2MM THRESHOLD. SEEG SURGERY PERFORMED THE (B)(6) 2022 ¿ ASSISTED BY CST - PROVIDED CORRECT RESULTS WITH A BETTER OPTIMIZATION OF LASER REGISTRATION CHECKED DURING THIS CASE. ALTHOUGH THE CAUSE FOR THE INACCURACIES CANNOT BE CONFIRMED, THIS ELEMENT PERMITS TO CONFIRM THAT THE DEVICE OPERATES WITHIN SPECIFICATIONS AS EXPECTED. IT WAS ALSO FOUND THAT THE PRE-OPERATIVE CT AND MRI EXAMS WERE NOT PROPERLY ADJUSTED TOGETHER. ANALYSIS ALSO PERMITTED TO DETERMINE THAT THIS ERROR RANDOMLY PERMITTED TO CORRECT TEMPORAL ELECTRODES INACCURATE PLACEMENT OF MORE THAN 1MM. ALL ELECTRODES WERE ACCURATELY PLACED REGARDING THE INITIAL PLAN PERFORMED ON MRI. UDI #: (B)(4).

    Description of Event or Problem · 0

    DR. (B)(6) DOES A SEEG PROCEDURES AND IN THE POST OP IMAGES HE SEES A TRANSLATION OF THE ELECTRODES. HE WOULD LIKE TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117227 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown