BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS BURR MOTOR

    MDR report key: 8097797 · Received November 21, 2018

    Report

    Report Number
    3005985723-2018-00689
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 26, 2018
    Report Date
    March 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT WHEN THE ANSPACH WAS POWERED THE BURR WOULD RELEASE. PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS THE PRODUCT WAS LOST AND HENCE WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: NOT PERFORMED AS IT IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 110940, S/N (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. 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. PRODUCT UNAVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    WHEN THE ANSPACH WAS POWERED THE BURR WOULD RELEASE. CASE TYPE: (B)(4).

    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

    WHEN THE ANSPACH WAS POWERED THE BURR WOULD RELEASE. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935801 ANSPACH EMAX 2 PLUS BURR MOTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization