BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8632850 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00368
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 16, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED ISSUE WE WERE HALF WAY THROUGH CUTS WHEN THE POWER TO THE MICS STOPPED WORKING. WE HAD LINED UP AND THE BORDER WAS GREEN TO HAVE POWER BUT NOTHING HAPPENED. I SHUT DOWN THE ROBOT, WAITED, SWITCHED OUT THE MICS, RESTARTED THE ROBOT AND IT FAILED MICS STATUS. I CALLED CLINICAL SUPPORT AND THEY SUGGESTED TO SHUT DOWN AGAIN SO I DID AND IT FAILED AGAIN. WE ONLY HAD THE 2 STERILE MICS BECAUSE WE USED ALL OF THEM THE DAY BEFORE S WE WERE FORCED TO GO MANUAL FOR THE DISTAL AND POSTERIOR CHAMFER CUT. TWO DIFFERENT MICS DIDN'T WORK AND NEED TO BE REPLACED FOR CASES MONDAY PLEASE. CASE TYPE: TKA. PRODUCT HISTORY REVIEW DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K0AWU AND (B)(4) INCLUDING 4203616 WERE ACCEPTED INTO FINAL STOCK ON 03/06/2018. A REVIEW OF QT18-03-0020 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)(6) IN PRODEX LOT K0AWU SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. 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

    WE WERE HALF WAY THROUGH CUTS WHEN THE POWER TO THE MICS STOPPED WORKING. WE HAD LINED UP AND THE BORDER WAS GREEN TO HAVE POWER BUT NOTHING HAPPENED. I SHUT DOWN THE ROBOT, WAITED, SWITCHED OUT THE MICS, RESTARTED THE ROBOT AND IT FAILED MICS STATUS. I CALLED CLINICAL SUPPORT AND THEY SUGGESTED TO SHUT DOWN AGAIN SO I DID AND IT FAILED AGAIN. WE ONLY HAD THE 2 STERILE MICS BECAUSE WE USED ALL OF THEM THE DAY BEFORE S WE WERE FORCED TO GO MANUAL FOR THE DISTAL AND POSTERIOR CHAMFER CUT. TWO DIFFERENT MICS DIDN'T WORK AND NEED TO BE REPLACED FOR CASES MONDAY PLEASE CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    WE WERE HAVE WAY THROUGH CUTS WHEN THE POWER TO THE MICS STOPPED WORKING. WE HAD LINED UP AND THE BORDER WAS GREEN TO HAVE POWER BUT NOTHING HAPPENED. I SHUT DOWN THE ROBOT, WAITED, SWITCHED OUT THE MICS, RESTARTED THE ROBOT AND IT FAILED MICS STATUS. I CALLED CLINICAL SUPPORT AND THEY SUGGESTED TO SHUT DOWN AGAIN SO I DID AND IT FAILED AGAIN. WE ONLY HAD THE 2 STERILE MICS BECAUSE WE USED ALL OF THEM THE DAY BEFORE S WE WERE FORCED TO GO MANUAL FOR THE DISTAL AND POSTERIOR CHAMFER CUT. TWO DIFFERENT MICS DIDN'T WORK AND NEED TO BE REPLACED FOR CASES MONDAY PLEASE. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424045 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42040818 / 4204684 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization