BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 7137592 · Received December 21, 2017

    Report

    Report Number
    3009185973-2017-00832
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 14, 2017
    Report Date
    May 17, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE REPORTED EVENT HAS BEEN COMPLETED AND CONFIRMED THAT THERE WAS A COMMUNICATION ISSUE WITH THE STAUBLI ROBOT. HOWEVER, THE LOG FILE IS INCOMPLETE AND THE CONTROLLER DID NOT RECORD ACTIONS FOR A PERIOD OF TIME. IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNRECOVERABLE ERROR OCCURED AFTER THE PLACEMENT OF A K-WIRE. THREE REBOOTS WERE NECESSARY TO RESTORE THE CONNECTION. THEN THE SURGEON PROCEEDED WITH THE CASE AND ADJUSTED THE ORIENTATION OF THE ROBOT ARM IN THE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919764 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.0.1266

    Patients

    Seq Age Sex Outcome Treatment
    1 Other