BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6791065 · Received August 14, 2017

    Report

    Report Number
    3005985723-2017-00376
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    August 9, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. IT WAS REPORTED THAT THE MICS WAS DISPLAYING ERROR MESSAGE DURING THE TKA CASE. THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS INDICATE 14 DEVICES WERE MANUFACTURED UNDER LOT K09GU AND 13 INCLUDING 4201246 WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2017. A REVIEW OF (B)(4) REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. A REVIEW OF COMPLAINTS RELATED TO PARTS IN P/N 209063 LOT NUMBER K09GU, SHOWS 01 OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: PR 1510197. THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A TKA CASE THREE (3) MICS PIECES ALL GAVE THE ERROR FAULT_HP_COMM DURING RIO SET UP. AFTER TROUBLESHOOTING ONCE MICS PASSES MICS STATUS CHECK BUT DURING THE FIRST CUT IT GAVE THE ERROR AGAIN. A FOURTH MICS WAS USED WITH NO ISSUE. THERE WAS A SURGICAL DELAY OF 10 MINUTES.

    Description of Event or Problem · 1

    DURING A TKA CASE THREE (3) MICS PIECES ALL GAVE THE ERROR FAULT_HP_COMM DURING RIO SET UP. AFTER TROUBLESHOOTING ONCE MICS PASSES MICS STATUS CHECK BUT DURING THE FIRST CUT IT GAVE THE ERROR AGAIN. A FOURTH MICS WAS USED WITH NO ISSUE. THERE WAS A SURGICAL DELAY OF 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571974 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization