BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6884633 · Received September 21, 2017

    Report

    Report Number
    3005985723-2017-00448
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 29, 2017
    Report Date
    December 1, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "REPORTED EVENT: IT WAS REPORTED THAT THE HANDPIECE DID NOT WORK. ISSUE WAS NOTICED BEFORE CASE, THEREFOR THERE WAS A 10 MINUTE CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08SH AND 25 INCLUDING 4201314 WERE ACCEPTED INTO FINAL STOCK ON 01/05/17. NO ISSUES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K08SH, P/N 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: UPON RECEIVING, MICS WORKED INTERMITTENTLY WHEN CABLE WAS EXERCISED, TURNING ON PROPERLY WHEN TRIGGER WAS PULLED AND OFF WHEN CABLE WAS MOVED. SHORTLY AFTER, MICS STOPPED WORKING. CONCLUSIONS: THE HANDPIECE DRIVER ELECTRONICS (COMMUTATION BOARD) COMMUNICATE WITH THE HANDPIECE TRIGGER. A FAILURE OF THIS COMMUNICATION WILL BREAK THE PROCESS THAT ALLOWS THE TRIGGER COMMAND TO RESULT IN THE MOTOR SPINNING. 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.

    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

    TWO MICS HANDPIECES FAILED MICS STATUS CHECK AND WE WERE UNABLE TO USE THEM. THERE WAS A SURGICAL DELAY OF 10 MINUTES. CASE TKA.

    Description of Event or Problem · 1

    TWO MICS HANDPIECES FAILED MICS STATUS CHECK AND WE WERE UNABLE TO USE THEM. THERE WAS A SURGICAL DELAY OF 10 MINUTES. CASE TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662475 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization