BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8034413 · Received November 2, 2018

    Report

    Report Number
    3005985723-2018-00647
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 17, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS TRIGGER GOT STUCK WHEN DEPRESSED AND THE SURGEON HAD TO PULL TRIGGER OUT TO RE-ENGAGE POWER. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES 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, PRODEX LOT K08UF SHOWS 3 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT (B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE MICS TRIGGER GOT STUCK WHEN DEPRESSED. SURGEON HAD TO PULL TRIGGER OUT TO RE-ENGAGE POWER. TKA. PER THE MPS, THE AWARENESS DATE IS (B)(6) 2018 AND THE MICS CONTINUED TO RUN WHILE OUTSIDE OF HAPTICS.

    Additional Manufacturer Narrative · 1

    AS PART OF 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

    THE MICS TRIGGER GOT STUCK WHEN DEPRESSED. SURGEON HAD TO PULL TRIGGER OUT TO RE-ENGAGE POWER. TKA. PER THE MPS, THE AWARENESS DATE IS (B)(6) 2018 AND THE MICS CONTINUED TO RUN WHILE OUTSIDE OF HAPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872653 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42041116/4201388 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization