BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6884645 · Received September 21, 2017

    Report

    Report Number
    3005985723-2017-00449
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    September 14, 2017
    Report Date
    December 15, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "REPORTED EVENT: IT WAS REPORTED THAT THE HANDPEICE DID NOT WORK. ISSUE WAS NOTICED DURING CASE, THEREFOR THERE WAS 5 MINUTES CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08BV AND 23 INCLUDING 4201064 WERE ACCEPTED INTO FINAL STOCK ON 09/15/16. A REVIEW OF (B)(4) SHOWED THAT THE FAILED PART WAS NOT RELATED TO THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K08BV, P/N 209063 SHOWS (B)(4) OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT INVESTIGATIONS ARE: (B)(4). MATERIAL INSPECTION: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE REPORTED ISSUE WAS FUNCTIONAL. VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. FUNCTIONAL INSPECTION: THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST ((B)(4)) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. SCREENSHOT OF PASSING TEST IS ATTACHED. CONCLUSIONS: FAILURE WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST ((B)(4)) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. 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

    AFTER THE SURGEON DID HIS ASSESSMENT HE DETERMINED THAT HE WANTED TO MAKE A COUPLE OF ADJUSTMENTS TO HIS TIBIA AND RECUT. WHEN ENTERING THE RIO VERIFICATION PORTION WE WERE NOT ABLE TO VERIFY RIO REGISTRATION. THE VALUE WAS AROUND 2.3MM. AFTER WE FAILED RIO VERIFICATION WE DID BASIC TROUBLESHOOTING, MAKING SURE BLADE WAS ENGAGED FULLY INTO ATTACHMENT, MAKE SURE HAND PIECE ATTACHED TO ROBOTIC ARM CORRECTLY. AT THAT POINT IT WAS DECIDED TO TRY AND USE A DIFFERENT MICS SYSTEM. WHILE TRYING TO SWITCH OUT THE MICS HAND PIECES THE SURGEON MADE THE DETERMINATION TO FINISH THE CASE USING MANUAL TECHNIQUES AND INSTRUMENTATION.

    Description of Event or Problem · 1

    AFTER THE SURGEON DID HIS ASSESSMENT HE DETERMINED THAT HE WANTED TO MAKE A COUPLE OF ADJUSTMENTS TO HIS TIBIA AND RECUT. WHEN ENTERING THE RIO VERIFICATION PORTION WE WERE NOT ABLE TO VERIFY RIO REGISTRATION. THE VALUE WAS AROUND 2.3MM. AFTER WE FAILED RIO VERIFICATION WE DID BASIC TROUBLESHOOTING, MAKING SURE BLADE WAS ENGAGED FULLY INTO ATTACHMENT, MAKE SURE HAND PIECE ATTACHED TO ROBOTIC ARM CORRECTLY. AT THAT POINT IT WAS DECIDED TO TRY AND USE A DIFFERENT MICS SYSTEM. WHILE TRYING TO SWITCH OUT THE MICS HAND PIECES THE SURGEON MADE THE DETERMINATION TO FINISH THE CASE USING MANUAL TECHNIQUES AND INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662716 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1