BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 14495654 · Received May 25, 2022

    Report

    Report Number
    3009185973-2022-00032
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 25, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    Z-0118-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HAS BEEN PERFORMED AND CONCLUDED THAT AN UNEXPECTED EMPTY CALIBRATION OCCURRED AFTER A RESTART DUE TO A COLLISION. THIS IS A KNOWN SOFTWARE ANOMALY THAT WAS ESCALATED AS A FIELD ACTION ZFA-2021-00198, FDA REFERENCE Z-0118-2022. THE FIELD SERVICE ENGINEER ADVISED A SPECIFIC MANIPULATION IN ORDER TO AVOID ANY DRIFT FOR THE REST OF THE SURGERY: THE TOOL WAS CAREFULLY REMOVED WHILE PERFORMING THE EMPTY CALIBRATION, AND THEN THE ROBOT ARM WAS SENT BACK TO HOME POSITION. THIS SOLVED THE ISSUE. THE INFORMATIONS FOR USE SPECIFIES THAT THE USER MUST BE VIGILANT AND ENSURE THAT NO COLLISION OCCURS. UDI#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SEEG, A COLLISION OCCURRED. WHEN THE DEVICE WAS RESTARTED, AN EMPTY CALIBRATION WAS ASKED. THE USER CLICKED ON START. THE USER REMOVED THE TOOL, PERFORMED THE EMPTY CALIBRATION, AND SENT THE ARM BACK TO HOME. THEN, THE TOOL WAS CALIBRATED AGAIN AND THE SURGERY CONTINUED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755462 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