BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8709673 · Received June 18, 2019

    Report

    Report Number
    3005985723-2019-00443
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 10, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING SOFTWARE ERROR INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 354 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR PKA SOFTWARE - SOFTWARE ERROR. CONCLUSION: INVESTIGATION COULD NOT BE PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED.

    Description of Event or Problem · 0

    USING THE PKA 3.0 , WHEN GOING TO DO FIRST TIBIAL CUT ON PLANAR WORKFLOW SURGEON STRUGGLED TO ALIGN AND STATED THAT THE ROBOT WISHED TO CUT TO MEDIALLY THAN PLANNED . ALL CHECKPOINTS PASSED AND RETOOK ALL LANDMARKS AND REGISTRATION AND SAME ISSUE WHEN GOING TO DO BONE CUTS . SURGEON DID NOT WANT TO PROCEED WITH MAKO AND COMPLETED A TKA . CASE TYPE: PKA. SURGICAL DELAY: 30-60 MINUTES. SURGERY WAS NOT 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

    USING THE PKA 3.0 , WHEN GOING TO DO FIRST TIBIAL CUT ON PLANAR WORKFLOW SURGEON STRUGGLED TO ALIGN AND STATED THAT THE ROBOT WISHED TO CUT TO MEDIALLY THAN PLANNED . ALL CHECKPOINTS PASSED AND RETOOK ALL LANDMARKS AND REGISTRATION AND SAME ISSUE WHEN GOING TO DO BONE CUTS . SURGEON DID NOT WANT TO PROCEED WITH MAKO AND COMPLETED A TKA . CASE TYPE: PKA. SURGICAL DELAY: 30-60 MINUTES. SURGERY WAS NOT COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501328 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization