BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS

    MDR report key: 7949376 · Received October 9, 2018

    Report

    Report Number
    3005985723-2018-00579
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 10, 2018
    Report Date
    November 1, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS (B)(6) REPORTED MICS STATUS CHECK FAIL. DEVICE EVALUATION AND RESULTS: "PER (B)(4) - THE MICS HAND PIECE WILL RUN WHEN EVER THE TRIGGER IS PRESSED. I REPLACED THE CPCI ASSEMBLY AND PERFORMED THE FOLLOWUP OUTLINED IN THE SERVICE MANUAL. THE OLD CPCI IS PART NUMBER 211123 LOT 21112347-3. THE NEW PART NUMBER IS 211123-R LOT 21112308. THE ROBOT IS READY FOR CLINICAL USE. " PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 05/18/16 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT16-04-0066, QT15-05-0040. 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 211123 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. PER (B)(4), 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. IT WAS CONFIRMED THAT MPS (B)(6) REPORTED MICS STATUS CHECK FAIL NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. 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

    (B)(4): MPS (B)(6) REPORTED MICS STATUS CHECK FAIL. UPDATE: CASE WAS CANCELED.

    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

    (B)(4): MPS (B)(6) REPORTED MICS STATUS CHECK FAIL. CASE WAS CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788471 CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 21112347-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization