BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9165868 · Received October 8, 2019

    Report

    Report Number
    3005985723-2019-00721
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 17, 2019
    Report Date
    January 13, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. BOTH GUNS DIED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA. PRODUCT INSPECTION PRODUCT WAS NOT INSPECTED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09Q7 AND 24 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 3 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINTS ARE (B)(4). CONCLUSION THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    BOTH GUNS DIED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA.

    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

    BOTH GUNS DIED. CASE TYPE: TKA. PATIENT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960304 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42040517 / 4202268 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization