BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8020239 · Received October 30, 2018

    Report

    Report Number
    3005985723-2018-00632
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 22, 2018
    Report Date
    March 8, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    PMA / PMN Number
    K170584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING SOFTWARE FREEZE WITH BLACK SCREEN INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: -DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 594 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. -COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING SOFTWARE FREEZE WITH BLACK SCREEN. THERE WERE 0 OTHER REPORTED EVENTS. -CONCLUSION: THERE ARE NO ERRORS INDICATIVE OF A SOFTWARE FREEZE DURING THE PKA SESSION LOG SUBMITTED FOR THIS INVESTIGATION. NO LOGS WERE SUBMITTED FOR EITHER THE TKA APPLICATION INSTALL OR THE TKA CASE WHICH EXPERIENCED SIMILAR SOFTWARE FREEZE. THIS INVESTIGATION IS INCONCLUSIVE.

    Description of Event or Problem · 0

    DURING PKA CASE AND SETUP OF TKA SOFTWARE HAD A COUPLE SOFTWARE FREEZES HAD TO HARD SHUTDOWN THE ROBOT FROM BACKSIDE OF ROBOT. ALSO HAD TO PERFORM SOFT REBOOT AND HARD REBOOT. BUT THEN BLACK SCREENED. SURGEON IS REQUESTING INFORMATION REGARDING REASON HAPPENING. SURGICAL DELAY-16-30 MINUTES YES 20 MINUTES, PATIENT WAS UNDER ANESTHESIA CASE TYPE: PKA.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING PKA CASE AND SETUP OF TKA SOFTWARE HAD A COUPLE SOFTWARE FREEZES HAD TO HARD SHUTDOWN THE ROBOT FROM BACKSIDE OF ROBOT. ALSO HAD TO PERFORM SOFT REBOOT AND HARD REBOOT. BUT THEN BLACK SCREENED. SURGEON IS REQUESTING INFORMATION REGARDING REASON HAPPENING. SURGICAL DELAY-16-30 MINUTES YES 20 MINUTES, PATIENT WAS UNDER ANESTHESIA. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859308 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization