BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7377058 · Received March 28, 2018

    Report

    Report Number
    3005985723-2018-00191
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 4, 2018
    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 · 0

    "REPORTED ISSUE THE HANDPIECE DID NOT WORK. PRODUCT HISTORY REVIEW DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08J6 AND 25 INCLUDING 4201196 WERE ACCEPTED INTO FINAL STOCK ON 2/28/17. A REVIEW OF QT17-02-0091 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K08J6 SHOWS 1 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4). VISUAL INSPECTION VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. DIMENSIONAL INSPECTION DIMENSIONAL INSPECTION WAS NOT COMPLETED. THE REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION FUNCTIONAL INSPECTION REVEALED NO PHYSICAL DAMAGE AND THE PRODUCT FUNCTIONED AS INTENDED. CONCLUSION FAILURE WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL."

    Description of Event or Problem · 0

    ROBOT STOPPED WORKING DURING INITIAL CUT. TKA CASE DELAYED FOR 10 MINUTES. WAS THE CASE COMPLETED MANUALLY? YES.

    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

    ROBOT STOPPED WORKING DURING INITIAL CUT. TKA CASE DELAYED FOR 10 MINUTES. WAS THE CASE COMPLETED MANUALLY? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220930 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42040916

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization