BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7970458 · Received October 16, 2018

    Report

    Report Number
    3005985723-2018-00593
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    October 1, 2018
    Report Date
    May 2, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE ROBOT WENT OUT OF HAPTICS, AS A MEASURE MICS WAS REPLACED. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND FAILED. THE MOTOR DID NOT SPIN DURING THE TEST. SCREENSHOT IS ATTACHED. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09GR AND 25 INCLUDING 4202041 WERE ACCEPTED INTO FINAL STOCK ON 05/01/2017. NO NON CONFORMANCE WERE IDENTIFIED DURING THE PROCESS. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, PRODEX LOT NUMBER K09GR SHOWS 08 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4). CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED TO BE ELECTRICAL ISSUE, THE MICS FAILED THE FUNCTIONALITY TEST WHICH LEAD TO ABNORMAL BEHAVIOR OF THE ROBOTIC ARM. 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

    GSP 166864: MPS (B)(6) REPORTED SAWBLADE GETTING POWER OUTSIDE HAPTICS. THIS IS THE SECOND INCIDENT THAT THIS IS OCCURRING. THE FIRST INCIDENT IS CAPTURED UNDER PR# (B)(4); TKA RESOLUTION: UPON ARRIVAL I COULD NOT DUPLICATE THE DESCRIBED PROBLEM. I DID FIND A FAULTY MICS HAND PIECE. INSTRUCTED MPS TO ORDER A NEW MICS HANDPIECE. I REPLACED THE CPCI ASSY TO TRY AND ISOLATE THE PROBLEM THE MPS DESCRIBED. COMPLETED A TKA SAWBONE WITH NO ISSUES TO PROVE THE SYSTEM IS WORKING. UPDATE: PATIENT WAS UNDER ANESTHESIA. CASE WAS COMPLETED MANUALLY.

    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 ODELL WOODS REPORTED SAWBLADE GETTING POWER OUTSIDE HAPTICS. THIS IS THE 2ND INCIDENT THAT THIS IS OCCURRING. THE FIRST INCIDENT IS CAPTURED UNDER PR# (B)(4); TKA. RESOLUTION: UPON ARRIVAL I COULD NOT DUPLICATE THE DESCRIBED PROBLEM. I DID FIND A FAULTY MICS HAND PIECE. INSTRUCTED MPS TO ORDER A NEW MICS HANDPIECE. I REPLACED THE CPCI ASSY TO TRY AND ISOLATE THE PROBLEM THE MPS DESCRIBED. COMPLETED A TKA SAWBONE WITH NO ISSUES TO PROVE THE SYSTEM IS WORKING. UPDATE: PATIENT WAS UNDER ANESTHESIA. CASE WAS COMPLETED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809324 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010417/4202064 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization