BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0

    MDR report key: 8633594 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00382
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 13, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS ERIC COTANT REPORTED FAILED MICS EVEN WHEN STATUS CHECK PASSES - SURGEON REQUESTS FSE VISIT. DEVICE EVALUATION AND RESULTS: PER (B)(4): ADJUSTED BUMP J2 STOP. PERFORMED KINEMATIC CALIBRATION BOTH SIDES. REPLACED MICS COMMUTATION ASSY. PERFORMED VERIFICATION TESTING TO CONFIRM THE ISSUE WAS RESOLVED. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 01/25/10 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 09-12-0128, NPR 09-12-0155, NPR 10-01-0022, NPR 10-01-0032, NPR 10-01-0070, NPR 10-01-0075, NPR 10-01-0087, NPR 10-01-0019, NPR 09-12-0034. 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 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4), MPS ERIC COTANT REPORTED FAILED MICS EVEN WHEN STATUS CHECK PASSES - SURGEON REQUESTS FSE VISIT. CASE TYPE: TKA. UPDATE: SURGICAL DELAY > 30 MIN. UPDATE: "PROCEDURE WAS COMPLETED ROBOTICALLY AFTER A LONG DELAY."

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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)(6) REPORTED FAILED MICS EVEN WHEN STATUS CHECK PASSES - SURGEON REQUESTS FSE VISIT. CASE TYPE: TKA. UPDATE: SURGICAL DELAY > 30 MIN. UPDATE: "PROCEDURE WAS COMPLETED ROBOTICALLY AFTER A LONG DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424668 CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization