BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9174470 · Received October 10, 2019

    Report

    Report Number
    3005985723-2019-00729
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 30, 2019
    Report Date
    January 15, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. ROBOT WOULD PASS REGISTRATION BUT WOULD NOT PASS VERIFICATION. MICS STATUS CHECK WOULD PASS. CLINICAL SUPPORT GUIDED ME TO HARD SHUTDOWN ROBOT BEFORE PUTTING ON NEW MICS. WE DID SO AND HAD TO REMOVE ROBOT WHILE STERILE. NEW MICS ALLOWED US TO PROCEED. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES. THE REPORTED EVENT REGARDING ISSUES PASSING VERIFICATION WAS NOT CONFIRMED. AN ISSUE WITH THE LOCKING MECHANISM WAS WAS NOTED UPON INSPECTION OF THE RETURNED DEVICE. PRODUCT INSPECTION MICS-209063 SN#4201940 LOT#42030317 RMA#281644 INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.4. FAILED COLLAR TEST. DISPOSITION: RTV INSPECTED BY: STEVEN HENRIQUEZ. THE DEVICE FAILURE MODE IDENTIFIED DURING INSPECTION IS NOT CONSISTENT WITH THE REPORTED ISSUE. DEVICE HISTORY REVIEW REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER PRODEX LOT K09CZ AND 23 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 04/27/2017. REVIEW OF QT17-04-0073 REVEALED THAT THE NON-CONFORMANCE 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 42030317 SHOWS 6 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION THE DEVICE FAILURE MODE IDENTIFIED DURING INSPECTION IS NOT CONSISTENT WITH THE REPORTED ISSUE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    ROBOT WOULD PASS REGISTRATION BUT WOULD NOT PASS VERIFICATION. MICS STATUS CHECK WOULD PASS. CLINICAL SUPPORT GUIDED ME TO HARD SHUTDOWN ROBOT BEFORE PUTTING ON NEW MICS. WE DID SO AND HAD TO REMOVE ROBOT WHILE STERILE. NEW MICS ALLOWED US TO PROCEED. 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

    ROBOT WOULD PASS REGISTRATION BUT WOULD NOT PASS VERIFICATION. MICS STATUS CHECK WOULD PASS. CLINICAL SUPPORT GUIDED ME TO HARD SHUTDOWN ROBOT BEFORE PUTTING ON NEW MICS. WE DID SO AND HAD TO REMOVE ROBOT WHILE STERILE. NEW MICS ALLOWED US TO PROCEED. CASE TYPE: TKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969222 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42030317 / 4201940 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization