BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 6575746 · Received May 18, 2017

    Report

    Report Number
    3005985723-2017-00223
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    April 21, 2017
    Report Date
    May 24, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IDENTIFICATION: THE REPORTED DEVICE WAS CONFIRMED TO BE AN ANGLE DISCREPANCY ERROR ON J5, P/N 209999, SERIAL NUMBER (B)(4). DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH (B)(4) FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED WITH NO NOTES OR COMMENTS. DEVICE EVALUATION AND RESULTS: PER GSP 146360: MPS (B)(6) REPORTED COULD NOT PASS PRE-SURGERY DUE TO AN ANGLE DISCREPANCY ERROR ON J5. RESOLUTION: SUCCESSFULLY ADJUSTED AND RE-TENSIONED J5 PER SERVICE MANUAL AND VERIFIED OPERATION. RAN SEVERAL OTHER TESTS TO VERIFY CORRECT OPERATION. COMPLETED SERVICE VISIT IN CONJUNCTION WITH MAKO SYSTEM PM. SYSTEM IS READY FOR CLINICAL USE. COMPLAINT REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO (B)(4) SHOWS NO COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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.

    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) - MPS (B)(6) REPORTED COULD NOT PASS PRE-SURGERY DUE TO AN ANGLE DISCREPANCY ERROR ON J5 SUBCASE 146360-1 NOTES 4/21/2017 21:09:32 BBLACK ACTION TYPE: DESCRIPTION THA 3.1.1.1, PKA 2.5.6.4, CRISIS 2.13.1.1, CRISIS 2.13.1.2K, TKA 1.0, CRISIS 2.13.2, MGO 1.1. PROBLEM: COULDN'T PASS PRE-SURGERY. J5 BINDING. SUBCASE 146360-1 ACTION TYPE: RESOLUTION, NOTES: THA 3.1.1.1 PKA 2.5.6.4, CRISIS 2.13.1.1, CRISIS 2.13.1.2K, TKA 1.0, CRISIS 2.13.2, MGO 1.1. RESOLUTION: BB 04/20/17 @ 6:00PM. SUCCESSFULLY ADJUSTED AND RE-TENSIONED J5 PER SERVICE MANUAL AND VERIFIED OPERATION. RAN SEVERAL OTHER TESTS TO VERIFY CORRECT OPERATION. COMPLETED SERVICE VISIT IN CONJUNCTION WITH MAKO SYSTEM PM. SYSTEM IS READY FOR CLINICAL USE. (B)(4).

    Description of Event or Problem · 1

    ROB415 - MPS (B)(6) REPORTED COULD NOT PASS PRE-SURGERY DUE TO AN ANGLE DISCREPANCY ERROR ON J5 SUBCASE 146360-1 NOTES 4/21/2017 21:09:32 BBLACK ACTION TYPE: DESCRIPTION THA 3.1.1.1 PKA 2.5.6.4 CRISIS 2.13.1.1 CRISIS 2.13.1.2K TKA 1.0 CRISIS 2.13.2 MGO 1.1. PROBLEM: COULDN'T PASS PRE-SURGERY. J5 BINDING. SUBCASE 146360-1 ACTION TYPE: RESOLUTION, NOTES: THA 3.1.1.1 PKA 2.5.6.4 CRISIS 2.13.1.1 CRISIS 2.13.1.2K TKA 1.0 CRISIS 2.13.2 MGO 1.1. RESOLUTION: BB (B)(6) 2017 @ 6:00PM. SUCCESSFULLY ADJUSTED AND RE-TENSIONED J5 PER SERVICE MANUAL AND VERIFIED OPERATION. RAN SEVERAL OTHER TESTS TO VERIFY CORRECT OPERATION. COMPLETED SERVICE VISIT IN CONJUNCTION WITH MAKO SYSTEM PM. SYSTEM IS READY FOR CLINICAL USE. , MODIFIED BY BBLACK ON 4/21/2017 9:13:17 PM SUBCASE 146360-1 CLOSED 4/21/2017 21:13:35 BBLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358299 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization