BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 6430916 · Received March 24, 2017

    Report

    Report Number
    3009185973-2017-00104
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    May 17, 2015
    Report Date
    March 16, 2017
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RO 14 042 HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT THE DEVICE WAS INCORRECTLY PREPARED FOR USE DURING THE INSTALLATION PHASE QND ASSEMBLED WITH AN INAPPROPRIATED CABLE. AS REPAIR, THE CABLE HAS BEEN REPLACED. THE INTERNAL COMPLAINT REFERENCE IS THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A SURGERY, THE CABLE/CONNECTOR WAS NON-FUNCTIONAL AND IT WAS NOT POSSIBLE TO USE THE ROSA SYSTEM. THE PROCEDURE HAS BEEN COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213931 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other