BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 9081359 · Received September 18, 2019

    Report

    Report Number
    3005985723-2019-00682
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 30, 2019
    Report Date
    November 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. MPS (B)(6) REPORTED HYDRAULIC FLUID LEAKING FROM THE ROBOT AND IT HAS BECOME NECESSARY TO USE THE WRENCH TO LIFT AND LOWER THE ROBOT. DEVICE EVALUATION AND RESULTS: PER WO-(B)(4): LOOSE FITTING ON HYDRAULIC JACK. TIGHTENED AND VERIFIED FITTING ON HYDRAULICS. ROBOT LIFTS UP WITH PEDAL AND NO LEAKING FLUID. REPLACED LOST HYDRAULIC FLUID. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 04/19/10 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 10- 03-0097, NPR 10-04-0053, NPR 10-04-0078, NPR 10-04-0074, NPR 10-04-0066, NPR 10-04-0049, NPR 10-03-0104. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209999 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4) - MPS (B)(6) REPORTED HYDRAULIC FLUID LEAKING FROM THE ROBOT AND IT HAS BECOME NECESSARY TO USE THE WRENCH TO LIFT AND LOWER THE ROBOT. CASE TYPE: PKA. UPDATE: "THERE IS NO PATIENT INFORMATION TO GIVE OUT BECAUSE THE PATIENT WAS NOT AFFECTED. ISSUE WAS NOTICED AFTER BONE PREPARATION. "PATIENT WAS UNDER ANESTHESIA." THERE WAS NO SURGICAL DELAY. SURGERY WAS COMPLETED ROBOTICALLY.

    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

    CASE NUMBER: (B)(4), ROB095 - MPS (B)(6) REPORTED HYDRAULIC FLUID LEAKING FROM THE ROBOT AND IT HAS BECOME NECESSARY TO USE THE WRENCH TO LIFT AND LOWER THE ROBOT. CASE TYPE: PKA. UPDATE: "THERE IS NO PATIENT INFORMATION TO GIVE OUT BECAUSE THE PATIENT WAS NOT AFFECTED. ISSUE WAS NOTICED AFTER BONE PREPARATION. "PATIENT WAS UNDER ANESTHESIA." THERE WAS NO SURGICAL DELAY. SURGERY WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874595 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization