BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCODER, J6, HIP 190-00137

    MDR report key: 7099602 · Received December 8, 2017

    Report

    Report Number
    3005985723-2017-00618
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 27, 2017
    Report Date
    February 23, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS REPORTED FAILED ANGLE DISCREPANCY J6. DEVICE EVALUATION AND RESULTS: PER (B)(4): - A LIQUID WAS TRAPPED BENEATH THE J6 ENCODER GLASS. FSE CLEANED J6 ENCODER WHEEL. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 01/24/2014 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 14-01-0016, NPR 14-01-0013, NPR 14-02-0004. 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 203486, SERIAL NUMBER (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PERFORM ALL PM CHECKS AND TESTS. PASSED ALL CHECKS AND TESTS. 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

    (B)(4) - MPS (B)(6) REPORTED FAILED ANGLE DISCREPANCY J6. A LIQUID WAS TRAPPED BENEATH THE J6 ENCODER GLASS. FSE CLEANED J6 ENCODER WHEEL. CASE TYPE: TKA. UPDATE: PER THE MPS, THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE ISSUE OCCURRED. THE SURGEON PROCEEDED MANUALLY.

    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)(6) REPORTED FAILED ANGLE DISCREPANCY J6. A LIQUID WAS TRAPPED BENEATH THE J6 ENCODER GLASS. FSE CLEANED J6 ENCODER WHEEL. CASE TYPE: TKA. UPDATE: PER THE MPS, THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE ISSUE OCCURRED. THE SURGEON PROCEEDED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878680 ENCODER, J6, HIP 190-00137 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization