BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LED, PUSHBUTTON AMBER BAYONET

    MDR report key: 8871215 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00568
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS (B)(6) REQUESTED SERVICE VISIT ON ROBOT. DEVICE EVALUATION AND RESULTS: PER (B)(4): MPS (B)(6) REQUESTED I CHECK THE SYSTEM FOR ANY ISSUES. SHE INDICATED THAT BRAKE RELEASE BUTTON LED BULB WASN'T TURNING ON. UPON ARRIVAL, CHECKED THE BRAKE RELEASE BULB AND IT WAS ON. REPLACED THE AMBER BAYONET LED BULB PART #200521 AS A PRECAUTION. CHECKED SYSTEM AND FOUND NOTHING WRONG AS IT WAS OPERATING NORMALLY WITH NO ISSUES. 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 11/18/2010 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 10-10-0025, NPR 10-10-0052, NPR 10-10-0072, NPR 10-10-0090, NPR 10-10-0115, NPR 10-11-0085, NPR 10-11-0054, NPR 10-11-0051, NPR 10-10-0019, NPR 10-10-0001, NPR 10-10-0037, NPR 10-10-0114, NPR 10-06-0159, NPR 10-06-0164, NPR 10-08-0008, NPR 10-10-0067, NPR 10-10-0009, NPR 10-10-0050, NPR 10-11-0065, NPR 10-11-0060 NPR 10-11-0073. 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 200521 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 (B)(6) REQUESTED SERVICE VISIT ON ROBOT. CASE TYPE: PKA. SURGICAL DELAY: <30 MIN.

    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), MPS (B)(6) REQUESTED SERVICE VISIT ON ROBOT. CASE TYPE: PKA. SURGICAL DELAY: <30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663887 LED, PUSHBUTTON AMBER BAYONET STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization