BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 9320788 · Received November 14, 2019

    Report

    Report Number
    3005985723-2019-00799
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 23, 2019
    Report Date
    January 20, 2020
    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

    MPS REPORTED ANGLE DISCREPANCY FAILURE IN J5. SURGERY WAS NOT COMPLETED ROBOTICALLY. DEVICE EVALUATION AND RESULTS: PER (B)(4): ERROR WAS ON J6 NOT J5. CLEANED J6 ENCODER, KIN-CAL BOTH SIDES. VERIFIED ROBOT NO LONGER HAS ERROR. COMPLETED ALL TESTING AND VERIFICATIONS. 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 06/26/2012 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 12-05-0098, NPR 12-05-0038. 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 201903 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). REPORTED ANGLE DISCREPANCY FAILURE IN J5. SURGERY WAS NOT COMPLETED ROBOTICALLY. UPDATE: CASE TYPE: TKA. ANY SURGICAL DELAY? (NO DELAY, < 15 MIN, < 30 MIN, = 30 MIN): YES <30 MIN. WAS THE CASE CANCELLED? (YES/NO) NO. WAS PROCEDURE COMPLETED SUCCESSFULLY? (YES/NO) YES. WAS PROCEDURE COMPLETED MANUALLY? (YES/NO ¿ EXPLAIN). YES, ROBOTIC FAILURE OCCURRED DURING INTRA-OP RIO. REGISTRATION. BONE REGISTRATION AND JOINT BALANCING WERE COMPLETE, BUT NO RESECTIONS WERE MADE WITH THE RIO. WAS THE PATIENT UNDER ANESTHESIA AT THE TIME OF THE ISSUE? (YES/NO) YES.

    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 (B)(6) REPORTED ANGLE DISCREPANCY FAILURE IN J5. SURGERY WAS NOT COMPLETED ROBOTICALLY. UPDATE: CASE TYPE: TKA. ANY SURGICAL DELAY? (NO DELAY, < 15 MIN, < 30 MIN, = 30 MIN): YES <30 MIN. WAS THE CASE CANCELLED? (YES/NO) NO. WAS PROCEDURE COMPLETED SUCCESSFULLY? (YES/NO) YES. WAS PROCEDURE COMPLETED MANUALLY? (YES/NO ¿ EXPLAIN) YES, ROBOTIC FAILURE. OCCURRED DURING INTRA-OP RIO REGISTRATION. BONE REGISTRATION AND JOINT BALANCING WERE COMPLETE, BUT NO RESECTIONS WERE MADE WITH THE RIO. WAS THE PATIENT UNDER ANESTHESIA AT THE TIME OF THE ISSUE? (YES/NO) YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117032 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization