BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 9646680 · Received January 30, 2020

    Report

    Report Number
    3005985723-2020-00062
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 7, 2020
    Report Date
    April 29, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO B2. REPORTED EVENT: IT WAS REPORTED THAT CASE NUMBER: (B)(4). ROB942 - CLPS REPORTED SPARKING/ARCING NOISE AND BURNING SMELL COMING FROM ROBOT WHEN TURNING ON CASE WAS COMPLETED MANUALLY. PRODUCT EVALUATION AND RESULTS: AS PER WO-02294322, COMPLETED DATE 1/10/2020: THE UPS WAS REPLACED. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR USE. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 1 DEVICE WAS MANUFACTURED AND ACCEPTED ON 06/14/2019 AFTER BEING HANDLED VIA QT 19-06-0039. THE NON CONFORMANCE IS UNRELATED TO THE FAILURE ALLEGED IN THE INVESTIGATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 202456, ROB942 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE IS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4). ROB942 - CLPS JAMES INGLE REPORTED SPARKING/ARCING NOISE AND BURNING SMELL COMING FROM ROBOT WHEN TURNING ON. CASE WAS COMPLETED MANUALLY.

    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

    CASE NUMBER: (B)(4). (B)(4) - CLPS (B)(6) REPORTED SPARKING/ARCING NOISE AND BURNING SMELL COMING FROM ROBOT WHEN TURNING ON. CASE WAS COMPLETED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110747 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O