BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8248299 · Received January 15, 2019

    Report

    Report Number
    3005985723-2019-00058
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    January 3, 2019
    Report Date
    March 26, 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

    REPORTED EVENT: AN EVENT REGARDING INCORRECT GREEN VISUAL REMOVAL DURING A TOTAL KNEE PROCEDURE INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 29 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: BASED ON THE DEVICE IDENTIFICATION (PN 209999) THE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING GREEN AREA NOT REMOVING DURING CUTTING. THERE WERE OTHER REPORTED EVENTS FOR THE LISTED CATALOG NUMBER (B)(4). CONCLUSION: RESOLUTION PER (B)(4): SUBCASE (B)(4) NOTES 1/6/2019 21:08:15 MVINSH ACTION TYPE: DESCRIPTION MV 1/4/2019. (B)(4). MPS (B)(6) REPORTED GREEN RESECTION AREA NOT DISAPPEARING DURING CUTTING. SUBCASE (B)(4) NOTES 1/6/2019 21:16:49 MVINSH ACTION TYPE: RESOLUTION MV 1/4/2019. (B)(6). (B)(4). PKA 2.5.6.4. THA 3.1.1.1. TKA 1.0. CRISIS 2.13.1.2K/2.13.1.1/2.13.2. MGO 1.1.8. UTILITIES 1.10. (B)(4) GREEN RESECTION AREA NOT DISAPPEARING DURING CUTTING. REPLACED CPCI ASSEMBLY. NOTICED CAMERA WAS LOOSE, TENSIONED SUPPORT SCREW. -CALIBRATION END EFFECTOR WAS NOT SEATED FIRM ONTO J6 AFTER TIGHTENING. REPLACED J6 SCREW INSERTS AND CAL EE SCREWS. ALL TESTING COMPLETE. SYSTEM IS READY FOR CLINICAL USE.

    Description of Event or Problem · 0

    (B)(4) - MPS (B)(6) REPORTED GREEN RESECTION AREA NOT DISAPPEARING DURING CUTTING DESCRIPTION OF EVENT: NO GREEN DISAPPEARING WHILE CUTTING. APPLICATION: TKA. CASE DELAY > 15.

    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

    (B)(4) - (B)(6) REPORTED GREEN RESECTION AREA NOT DISAPPEARING DURING CUTTING. DESCRIPTION OF EVENT: NO GREEN DISAPPEARING WHILE CUTTING. APPLICATION: TKA. CASE DELAY: >15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43242 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization