BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8955795 · Received September 3, 2019

    Report

    Report Number
    3005985723-2019-00638
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 27, 2019
    Report Date
    April 14, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTRAOP OP RIO SET UP & REGISTERED THE ROBOT (IDENTIFIED THAT MICS CONNECTION WAS SUCCESSFUL. UPON ENTERING BONE CUTS, NO POWER TO MICS. ATTEMPTED TO RESET CUTTER & WAIT 10SECONDS WITH NO AVAIL. EXIT PAGE & RE-ENTERED WITH NO AVAIL. DISCONNECTED & RECONNECTED THE MICS WITH NO AVAIL. DID MICS STATUS CHECK & FAILED WITH NO POWER. SHUTDOWN ROBOT ON MODULE & REHOMED AS WELL AS ARM STATUS REBOOT, THEN MICS STATUS AGAIN WITH NO AVAIL. CHANGED MICS. ATTEMPTED MICS STATUS CHECK & FAILED. CONTACTED TEAM MATES & FSE, PROCEED TO THEN COMPLETE A HARD SHUTDOWN WAITING 2MINS ROBOT, ATTEMPTED MICS STATUS CHECK & FAILED. SURGEON PROCEEDED TO MANUAL RIGHT TKA UTILIZING AS MUCH INFORMATION ATTAINED FOR BONE RESECTION AMOUNTS FROM LIGAMENT BALANCING. SURGEON INFORMED PATIENT CASE WAS NOT COMPLETED ROBOTICALLY. PRODUCT INSPECTION: AS PER SERVICE MAXWO-02133974 & CASE NUMBER (B)(4). MICS-209063, SN#: (B)(6), LOT#42040517, RMA#282213. INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.3. FAILED PIVOT LOCK HANDLE TEST. DISPOSITION: RTV. INSPECTED BY: (B)(4). THE ALLEGED FAILURE WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K09Q7 AND (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 06-21-2017. A REVIEW OF QT17-06-0068 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42040517 SHOWS 8 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION THE ALLEGED FAILURE WAS NOT CONFIRMED . NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    WHEN THIS DECISION WAS ACCESSED IT WAS DONE SO THROUGH A DIFFERENT CRITERIA. UPON FURTHER INVESTIGATION THE CONCLUSION, PER OUR RISK DOCUMENTATION, HAS BEEN UPDATED AND THE BELOW IS THE NO REPORT RATIONALE. WE HAVE REVALUATED THE REPORTABILITY OF THIS EVENT AND HAVE ESTABLISHED THAT THIS REPORTED HAZARDOUS SITUATION HAS NOT RESULTED IN ANY PATIENT HARMS ASSOCIATED WITH AN S3,03 OR HIGHER. A REVIEW OF THE FOR TOTAL KNEE ARTHROPLASTY MAKO SYSTEM A0017400. FOR SYSTEM EXPERIENCES UNRECOVERABLE MALFUNCTION INDICATES THAT THE HIGHEST POTENTIAL SEVERITY OF HARM IS S2 WITH A POTENTIAL OCCURRENCE LEVEL O3. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DATA FOR THE PAST 4 YEARS INDICATED THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATH AS A RESULT OF SIMILAR EVENTS WITH THIS DEVICE FAMILY. BASED UPON THIS REVIEW, IT IS UNLIKELY THAT A SERIOUS INJURY OR DEATH WOULD RESULT IF THIS EVENT WERE TO RECUR. THEREFORE, THIS EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    INTRAOP OP RIO SET UP & REGISTERED THE ROBOT (IDENTIFIED THAT MICS CONNECTION WAS SUCCESSFUL. UPON ENTERING BONE CUTS, NO POWER TO MICS. ATTEMPTED TO RESET CUTTER & WAIT 10SECONDS WITH NO AVAIL. EXIT PAGE & RE-ENTERED WITH NO AVAIL. DISCONNECTED & RECONNECTED THE MICS WITH NO AVAIL. DID MICS STATUS CHECK & FAILED WITH NO POWER. SHUTDOWN ROBOT ON MODULE & REHOMED AS WELL AS ARM STATUS REBOOT, THEN MICS STATUS AGAIN WITH NO AVAIL. CHANGED MICS. ATTEMPTED MICS STATUS CHECK & FAILED. CONTACTED TEAM MATES & FSE, PROCEED TO THEN COMPLETE A HARD SHUTDOWN WAITING 2MINS ROBOT, ATTEMPTED MICS STATUS CHECK & FAILED. SURGEON PROCEEDED TO MANUAL RIGHT TKA UTILIZING AS MUCH INFORMATION ATTAINED FOR BONE RESECTION AMOUNTS FROM LIGAMENT BALANCING. SURGEON INFORMED PATIENT CASE WAS NOT COMPLETED ROBOTICALLY. SURGICAL DELAY OF 20 MINUTES CASE TYPE: TKA.

    Description of Event or Problem · 0

    INTRAOP OP RIO SET UP & REGISTERED THE ROBOT (IDENTIFIED THAT MICS CONNECTION WAS SUCCESSFUL. UPON ENTERING BONE CUTS, NO POWER TO MICS. ATTEMPTED TO RESET CUTTER & WAIT 10SECONDS WITH NO AVAIL. EXIT PAGE & RE-ENTERED WITH NO AVAIL. DISCONNECTED & RECONNECTED THE MICS WITH NO AVAIL. DID MICS STATUS CHECK & FAILED WITH NO POWER. SHUTDOWN ROBOT ON MODULE & REHOMED AS WELL AS ARM STATUS REBOOT, THEN MICS STATUS AGAIN WITH NO AVAIL. CHANGED MICS. ATTEMPTED MICS STATUS CHECK & FAILED. CONTACTED TEAM MATES & FSE, PROCEED TO THEN COMPLETE A HARD SHUTDOWN WAITING 2MINS ROBOT, ATTEMPTED MICS STATUS CHECK & FAILED. SURGEON PROCEEDED TO MANUAL RIGHT TKA UTILIZING AS MUCH INFORMATION ATTAINED FOR BONE RESECTION AMOUNTS FROM LIGAMENT BALANCING. SURGEON INFORMED PATIENT CASE WAS NOT COMPLETED ROBOTICALLY. SURGICAL DELAY OF 20 MINUTES CASE TYPE: TKA.

    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

    INTRAOP OP RIO SET UP & REGISTERED THE ROBOT (IDENTIFIED THAT MICS CONNECTION WAS SUCCESSFUL. UPON ENTERING BONE CUTS, NO POWER TO MICS. ATTEMPTED TO RESET CUTTER & WAIT 10 SECONDS WITH NO AVAIL. EXIT PAGE & RE-ENTERED WITH NO AVAIL. DISCONNECTED & RECONNECTED THE MICS WITH NO AVAIL. DID MICS STATUS CHECK & FAILED WITH NO POWER. SHUTDOWN ROBOT ON MODULE & REHOMED AS WELL AS ARM STATUS REBOOT, THEN MICS STATUS AGAIN WITH NO AVAIL. CHANGED MICS. ATTEMPTED MICS STATUS CHECK & FAILED. CONTACTED TEAM MATES & FSE, PROCEED TO THEN COMPLETE A HARD SHUTDOWN WAITING 2 MINS ROBOT, ATTEMPTED MICS STATUS CHECK & FAILED. SURGEON PROCEEDED TO MANUAL RIGHT TKA UTILIZING AS MUCH INFORMATION ATTAINED FOR BONE RESECTION AMOUNTS FROM LIGAMENT BALANCING. SURGEON INFORMED PATIENT CASE WAS NOT COMPLETED ROBOTICALLY. SURGICAL DELAY OF 20 MINUTES. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751318 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 LOT: 42051116 SN: 4201429 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization