BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 15107934 · Received July 26, 2022

    Report

    Report Number
    3005985723-2022-00099
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 5, 2022
    Report Date
    November 16, 2022
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ARM HAPTIC ISSUE INVOLVING A MAKO ROBOTIC ARM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS. -PRODUCT EVALUATION AND RESULTS: THE FIELD SERVICE ENGINEER REPORTED: PROBLEM REPRODUCED? NO. TROUBLE SHOOTING NOTES: NONE. WORK PERFORMED: ACTUAL ISSUE INDICATED. INVESTIGATED FOR REPORTED ISSUE, FOUND BOTH LEFT AND RIGHT SIDES REQUIRE KINETIC CALIBRATION. SUCCESSFULLY PERFORMED KINETIC CALIBRATION ON BOTH LEFT AND RIGHT SIDES. PERFORMED PM SERVICE. VERIFIED SYSTEM IS OPERATING WITHIN MAKO TOLERANCES AND SPECIFICATIONS. SYSTEM SUCCESSFULLY PASSED ALL VALIDATION TESTING. NO PARTS USED. 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. CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE ARE NO OTHER COMPLAINTS WITH A SIMILAR FAILURE MODE FOR THIS LOT. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED. SUCCESSFULLY COMPLETED ALL CHECKS, VERIFICATIONS, AND CALIBRATIONS. SYSTEM IS READY FOR CLINICAL USE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    ASE NUMBER: 10602584: MPS REPORTED ARM PULLING ITSELF OUT OF HAPTICS AND GREEN GOING AWAY DESPITE NO ACTUAL CUTS BEING MADE. ISSUE OBSERVED WHEN USING THE ANGLED SAWBLADE ATTACHMENT. SURGEON OPTED TO GO MANUAL INSTEAD OF US SEEING IF THIS SAME ISSUE OCCURRED WITH THE STRAIGHT SAWBLADE ATTACHMENT. MPS DID A FULL SHUTDOWN OF THE ROBOT, SWAPPED MICS HANDPIECES, AND THEN TURNED THE ROBOT BACK ON BUT THE SAME ISSUE WAS OBSERVED WITH THE 2ND HANDPIECE. I CONFIRMED THAT SAWBLADE AND BONE CHECKPOINT PASSED JUST PRIOR TO ATTEMPTING TO CUT. UPDATE: SUCCESSFULLY PERFORMED KINETIC CALIBRATION ON BOTH LEFT AND RIGHT SIDES. PERFORMED PM SERVICE. VERIFIED SYSTEM IS OPERATING WITHIN MAKO TOLERANCES AND SPECIFICATIONS. SYSTEM SUCCESSFULLY PASSED ALL VALIDATION TESTING. NO PARTS USED. SYSTEM IS READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4): MPS REPORTED ARM PULLING ITSELF OUT OF HAPTICS AND GREEN GOING AWAY DESPITE NO ACTUAL CUTS BEING MADE. ISSUE OBSERVED WHEN USING THE ANGLED SAWBLADE ATTACHMENT. SURGEON OPTED TO GO MANUAL INSTEAD OF US SEEING IF THIS SAME ISSUE OCCURRED WITH THE STRAIGHT SAWBLADE ATTACHMENT. MPS DID A FULL SHUTDOWN OF THE ROBOT, SWAPPED MICS HANDPIECES, AND THEN TURNED THE ROBOT BACK ON BUT THE SAME ISSUE WAS OBSERVED WITH THE 2ND HANDPIECE. I CONFIRMED THAT SAWBLADE AND BONE CHECKPOINT PASSED JUST PRIOR TO ATTEMPTING TO CUT. UPDATE: SUCCESSFULLY PERFORMED KINETIC CALIBRATION ON BOTH LEFT AND RIGHT SIDES. PERFORMED PM SERVICE. VERIFIED SYSTEM IS OPERATING WITHIN MAKO TOLERANCES AND SPECIFICATIONS. SYSTEM SUCCESSFULLY PASSED ALL VALIDATION TESTING. NO PARTS USED. SYSTEM IS READY FOR CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633166 3.0 RIO® ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other