BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 9602182 · Received January 17, 2020

    Report

    Report Number
    3005985723-2020-00046
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 20, 2019
    Report Date
    June 3, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT CASE NUMBER: (B)(4) MPS (B)(6) REPORTED HYDRAULIC FLUID LEAKING. CASE TYPE: TKA. UPDATE: "NO ASSOCIATED PROCEDURE. THIS ISSUE WAS NOTICED WHEN THE ROBOT WAS BROUGHT OUT OF THE STORAGE CLOSET AT THE HOSPITAL FOR USE. IT WAS AT HOSPITAL BEFORE. THERE WAS NO CASE DELAY." PRODUCT EVALUATION AND RESULTS: AS PER WORK ORDER, COMPLETED DATE 12/26/2019: REPLACED HYDRAULIC FOOT PUMP. TEST MEASUREMENT AT START OF HOLD TEST, 10"7/8THS. AT END OF HOLD TEST 10"7/8THS. TEST PASSED SUCCESSFULLY. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(6) WAS INSPECTED AND ACCEPTED INTO FINAL STOCK ON 08/13/2019 AFTER BEING HANDLED VIA QT. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCE 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: 200135, (B)(6) SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: PER 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 FAILURE IS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4) MPS REPORTED HYDRAULIC FLUID LEAKING. CASE TYPE: TKA. UPDATE: "NO ASSOCIATED PROCEDURE. THIS ISSUE WAS NOTICED WHEN THE ROBOT WAS BROUGHT OUT OF THE STORAGE CLOSET AT THE HOSPITAL FOR USE. THERE WAS NO CASE DELAY."

    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) - MPS REPORTED HYDRAULIC FLUID LEAKING. CASE TYPE: TKA. UPDATE: "NO ASSOCIATED PROCEDURE. THIS ISSUE WAS NOTICED WHEN THE ROBOT WAS BROUGHT OUT OF THE STORAGE CLOSET AT THE HOSPITAL FOR USE. THERE WAS NO CASE DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65004 3.0 RIO® ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 UNKNOWN 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other