BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA

    MDR report key: 12127136 · Received July 7, 2021

    Report

    Report Number
    3009185973-2021-00167
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 8, 2021
    Report Date
    February 18, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA PROVIDED FOR INVESTIGATION HAS BEEN PERFORMED. UNFORTUNATELY, A LACK OF INFORMATION DID NOT PERMIT TO CONFIRM THE ISSUE. IT WAS CONFIRMED THAT THE ARM MADE A SOUND IN A PREDEFINED POSITION WITH A DISTANCE SENSOR ATTACHED TO THE ARM. HOWEVER, THAT SOUND CANNOT BE CONSIDERED AS ABNORMAL SINCE THE ENVIRONMENT OF THE ROOM IS UNKNOWN AND THAT A SIMPLE MECHANICAL CONSTRAINT ON MOTORS COULD BE A NORMAL CAUSE FOR THIS SOUND.

    Description of Event or Problem · 0

    DURING THE MAINTENANCE OF ROSA 2.5, ABNORMAL SOUND WAS FOUND IN THE MOVING PROCESS OF THE MANIPULATOR ARM.

    Additional Manufacturer Narrative · 1

    UDI# : NOT APPLICABLE (DEVICE MANUFACTURED BEFORE 2016). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE MAINTENANCE OF ROSA 2.5, ABNORMAL SOUND WAS FOUND IN THE MOVING PROCESS OF THE MANIPULATOR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023983 ROSA COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA 2.5 2.5.8.4

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown