BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7538812 · Received May 23, 2018

    Report

    Report Number
    3005985723-2018-00307
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    April 16, 2018
    Report Date
    March 1, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF INVESTIGATION. UPDATED 510K # K142530. REPORTED ISSUE: END USER HAS REPORTED THAT THE ANGLED SAW PASSED RIGHT AWAY BUT THE STRAIGHT ATTACHMENT DID NOT PASS. THEY REREGISTERED THE ROBOT AND IT PASSED. THEY WENT BACK TO CHECK TO SEE IF THE FIRST TWO CUTS WERE OFF, USING THE PLANAR PROBE, AND IT WAS READING 1.5-2MM DEEP. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED UNDER LOT K0A8J AND 24 INCLUDING 4202924 WERE ACCEPTED INTO FINAL STOCK ON 10/03/2017. A REVIEW OF QT17-10-0006 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N (B)(4) IN PRODEX LOT K0A8J SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. THE REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION REVEALED NO PHYSICAL DAMAGE AND THE PRODUCT FUNCTIONED AS INTENDED. CONCLUSION: FAILURE WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL.

    Description of Event or Problem · 0

    END USER HAS REPORTED THAT THE ANGLED SAW PASSED RIGHT AWAY BUT THE STRAIGHT ATTACHMENT DID NOT PASS. THEY REREGISTERED THE ROBOT AND IT PASSED. THEY WENT BACK TO CHECK TO SEE IF THE FIRST TWO CUTS WERE OFF, USING THE PLANAR PROBE, AND IT WAS READING 1.5-2MM DEEP. TKA PROCEDURE.

    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

    END USER HAS REPORTED THAT THE ANGLED SAW PASSED RIGHT AWAY BUT THE STRAIGHT ATTACHMENT DID NOT PASS. THEY REREGISTERED THE ROBOT AND IT PASSED. THEY WENT BACK TO CHECK TO SEE IF THE FIRST TWO CUTS WERE OFF, USING THE PLANAR PROBE, AND IT WAS READING 1.5-2MM DEEP. TKA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380984 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202924

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization