BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 8673594 · Received June 6, 2019

    Report

    Report Number
    3009185973-2019-00198
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 6, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A COMMUNICATION FAILURE OCCURRED DURING A SURGERY. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION SEVERAL CONNECTIONS TO THE ROBOT ARM FAILED PROVOKED BY THE BAD CONNECTION OR DISCONNECTION OF THE NI DAQ ACQUISITION CARD. THE DISTRIBUTOR INDICATED THAT THE NI DAQ ACQUISITION CARD MAY HAVE BEEN DISCONNECTED DURING TRANSPORTATION OF THE DEVICE. THIS IS THE MOST PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COMMUNICATION FAILURE OCCURRED DUE TO AN ISSUE WITH NI DAQ CARD CONNECTION DURING A SURGERY. THIS EVENT CAUSED A 30 MINUTES DELAY AND NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468563 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8.4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other