BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH® EMAX2 PLUS MOTOR

    MDR report key: 8785581 · Received July 12, 2019

    Report

    Report Number
    3005985723-2019-00506
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ANSPACH EMAX 2 PLUS BURR MOTOR BURR LOST POWER AND BEGAN TO COME LOOSE. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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 BURR LOST POWER AND BEGAN TO COME LOOSE FAILURE OF P/N: EMAX2PLUS, S/N: (B)(6). THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REFERENCED SERIAL NUMBER. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. 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

    MAKO PRODUCT SPECIALIST REPORTED THAT DURING A CASE, PROBLEMS WERE ENCOUNTERED WITH THE ANSPACH. THE BURR LOST POWER AND BEGAN TO COME LOOSE. ANOTHER EQUIPMENT WAS USED TO COMPLETE THE CASE. THERE WAS A DELAY OF APPROXIMATELY 40 MINUTES BECAUSE THE HOSPITAL STAFF HAD INTERNAL TROUBLE SOURCING THE EQUIPMENT. DELAY OF APPROXIMATELY 40 MINUTES.

    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

    MAKO PRODUCT SPECIALIST REPORTED THAT DURING A CASE, PROBLEMS WERE ENCOUNTERED WITH THE ANSPACH. THE BURR LOST POWER AND BEGAN TO COME LOOSE. ANOTHER EQUIPMENT WAS USED TO COMPLETE THE CASE. THERE WAS A DELAY OF APPROXIMATELY 40 MINUTES BECAUSE THE HOSPITAL STAFF HAD INTERNAL TROUBLE SOURCING THE EQUIPMENT. DELAY OF APPROXIMATELY 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579842 ANSPACH® EMAX2 PLUS MOTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. MD6312953009

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization