BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 8240145 · Received January 11, 2019

    Report

    Report Number
    3005985723-2019-00049
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    January 10, 2019
    Report Date
    March 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ANSPACH EMAX 2 PLUS BURR MOTOR E2 ERROR. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE ANSPACH EMAX 2 PLUS BURR MOTOR EVENT WAS CONFIRMED. ALSO, ANSPACH EMAX 2 PLUS BURR MOTOR MADE LOUD BEARING NOISE AND ANSPACH MOTOR BODY GETS WARM (<80,000 RPM'S). COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING ANSPACH EMAX 2 PLUS BURR MOTOR E2 ERROR FAILURE OF P/N: 110940, S/N: (B)(4). THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REFERENCED SERIAL NUMBER. CONCLUSIONS: THE ANSPACH EMAX 2 PLUS BURR MOTOR IS AN OEM DEVICE. UPON RECEIPT, THE ANSPACH EMAX 2 PLUS BURR MOTOR WAS BENCH EVALUATED BY (B)(4) (ENGINEER, R&D ROBOTICS) AND THE REPORTED EVENT WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: AS THE EVENT DID NOT INVOLVE A MANUFACTURING RELATED PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND, OR UNANTICIPATED HAZARD, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    GAVE E2 ERROR. COULD NOT COMPLETE CASE. CHANGED TO SECOND ANSPACH. SAME ERROR. INSTRUCTED MY MAKO CLINICAL SUPPORT TO REPORT AND RETURN. CASE TYPE: PKA. SURGICAL DELAY: 16-30 MINUTES.

    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

    GAVE E2 ERROR. COULD NOT COMPLETE CASE. CHANGED TO SECOND ANSPACH. SAME ERROR. INSTRUCTED MY MAKO CLINICAL SUPPORT TO REPORT AND RETURN. CASE TYPE: PKA. SURGICAL DELAY: 16-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33971 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization