BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO ROBOTIC ARM - MICS

    MDR report key: 10725724 · Received October 23, 2020

    Report

    Report Number
    3005985723-2020-00320
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 16, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS REPORTED ARM BOUNCING AND SHAKING WHEN ENTERING HAPTICS AND DURING CUTS. THEY WERE ABLE TO GET THROUGH THE CASE. THE FIELD SERVICE ENGINEER REPORTED: PROBLEM REPRODUCED? YES TROUBLE SHOOTING NOTES: NONE WORK PERFORMED: UPON ARRIVING AT SITE I ASSUMED I WOULD BE RE-TENSIONING THE J5 CABLE TO ELIMINATE THE SHAKING TAMI (MPS) DESCRIBED. I DID RETENTION THE CABLE BUT OBSERVED ON MY TRANMISSION READINGS THAT ALTHOUGH TENSIONED, THE NOMINAL VALUES I WAS TRYING TO OBTAIN WERE NOT SUSTAINABLE. UPON CLOSER EVALUATION OF THE CABLE I COULD SEE AND FEEL SMALL FRAYING ON THE TUNGSTON CABLE. I DETERMINED THAT IT WOULD BE NECESSARY TO REPLACE THE J5 TRANSMISSION CABLE. REPLACED J5 TRANSMISSION CABLES, BOTH INSIDE AND OUTSIDE PTS#203250 AND 203251 PER SERVICE MANUAL AND ADJUSTED FOR CORRECT TENSIONING. ALSO REPLACED TIGHTENING ALLEN HEAD LOCK INSERT PT#203856. SUCCESSFULLY COMPLETED ALL CORRESPONDING TESTING PER SERVICE MANUAL. NOTIFIED MPS OF MY RESULTS. SYSTEM IS READY FOR CLINICAL USE. WORK ORDER DISPOSITION: SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED, SYSTEM IS READY FOR USE. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 12/15/2011, 01 DEVICE WAS MANUFACTURED. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209999, SERIAL NUMBER (B)(6) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4): MPS REPORTED ARM BOUNCING AND SHAKING WHEN ENTERING HAPTICS AND DURING CUTS. THEY WERE ABLE TO GET THROUGH THE CASE. UPDATE: SURGICAL DELAY: APPROXIMATELY 15-20 MIN; LEFT TKA

    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): MPS REPORTED ARM BOUNCING AND SHAKING WHEN ENTERING HAPTICS, AND DURING CUTS. THEY WERE ABLE TO GET THROUGH THE CASE. UPDATE: SURGICAL DELAY: APPROXIMATELY 15-20 MIN; LEFT TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193923 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other