BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9663232 · Received February 4, 2020

    Report

    Report Number
    3005985723-2020-00067
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 9, 2020
    Report Date
    March 26, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MICS HANDPIECE ASSEMBLY HAD WARNING OF OVERHEAT, AND A FEW OTHER WARNINGS. WOULD NOT WORK/NO POWER. PRODUCT INSPECTION: ORIGINAL DESCRIPTION CONFIRMED. MICS-209063, SN# (B)(6) , RMA# (B)(4). INSPECTED PER D06917 AND DETERMINED FAILURE OF THE FOLLOWING TEST STEP. SEC# 7.1.2. VISUAL OVER HEATING. DISPOSITION: RTV. INSPECTED BY: (B)(6) . DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4)WERE MANUFACTURED UNDER PRODEX LOT K08UF AND 24 WERE ACCEPTED INTO FINAL STOCK ON 01/25/2017. A REVIEW OF QT17-01-0086 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42041116 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION CONCLUSION: PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. NC/CAPA REVIEW: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    MICS HANDPIECE ASSEMBLY HAD WARNING OF OVERHEAT, AND A FEW OTHER WARNINGS. WOULD NOT WORK/NO POWER. 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

    MICS HANDPIECE ASSEMBLY HAD WARNING OF OVERHEAT, AND A FEW OTHER WARNINGS. WOULD NOT WORK/NO POWER. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130044 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42041116 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other