BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCODER ASSY J4: 195-00597

    MDR report key: 8664412 · Received June 3, 2019

    Report

    Report Number
    3005985723-2019-00402
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 16, 2019
    Report Date
    October 21, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: MPS (B)(6) REPORTED JOINT ANGLE INCONSISTENT ERROR ON J4. DEVICE EVALUATION AND RESULTS: PER WO-01649974: REPLACED J4 ENCODER ASSY. 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 08/03/17 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 17-07-0042, QT 17-07-0043, QT 17-07-0074, QT 17-07-0060, QT 17-07-0061, QT 17-07-0059. 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 207149 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

    MPS (B)(6). REPORTED JOINT ANGLE INCONSISTENT ERROR ON J4 ASSET: ROB603 CASE NUMBER: 03583158. CASE TYPE: TKA. UPDATE: SURGERY WAS COMPLETED MANUALLY. SURGICAL DELAY APPROXIMATELY 20MIN. PATIENT UNDER ANETHESIA.

    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

    MPS (B)(6) REPORTED JOINT ANGLE INCONSISTENT ERROR ON J4; ASSET: ROB603, CASE NUMBER: (B)(4). CASE TYPE: TKA. UPDATE: SURGERY WAS COMPLETED MANUALLY. SURGICAL DELAY APPROXIMATELY 20MIN. PATIENT UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458337 ENCODER ASSY J4: 195-00597 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization