BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 7674722 · Received July 10, 2018

    Report

    Report Number
    3005985723-2018-00411
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 25, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    PMA / PMN Number
    K170584
    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 MANUFACTURER NAME, CITY AND STATE, MFR SITE, DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP, WHAT TYPE AND DEVICE EVALUATED BY MFR BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: "MPS REPORTED J5 ERROR DURING RIO REGISTRATION." DEVICE EVALUATION AND RESULTS: PER GSP 165966: COULD NOT DUPLICATE PROBLEM. SUCCESSFULLY TESTED AND PASSED JOINT 5. SYSTEM SUCCESSFULLY PASSED ALL VALIDATION TESTING. VERIFIED SYSTEM IS OPERATING WITHIN MAKO TOLERANCES AND SPECIFICATIONS. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 09/20/2016 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 16-08-0074, QT 16-08-0098, QT 16-09-0008, QT 16-09-0048. 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, SERIAL NUMBER: (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. 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.

    Description of Event or Problem · 0

    ROBOT WOULD NOT REGISTER FOR CASE. PKA PROCEDURE DELAYED 16-30 MINUTES. ADDITIONAL INFORMATION: THE CASE WAS CANCELED. PATIENT WAS UNDER ANESTHESIA DURING THE REPORTED DELAY.

    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

    ROBOT WOULD NOT REGISTER FOR CASE. PKA PROCEDURE DELAYED 16-30 MINUTES. THE CASE WAS CANCELED. PATIENT WAS UNDER ANESTHESIA DURING THE REPORTED DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517580 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization