BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6145946 · Received December 5, 2016

    Report

    Report Number
    3005985723-2016-00412
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    November 23, 2016
    Report Date
    January 12, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: IT WAS REPORTED THAT A HANDPIECE WAS NOT FUNCTIONING. ISSUE WAS NOTICED PRIOR TO A CASE, THERE WAS A CASE DELAY AND THE CASE WAS COMPLETED MANUAL. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K0672 AND (B)(4) INCLUDING 4000316 WERE ACCEPTED INTO FINAL STOCK ON 11/12/2015. " VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. FUNCTIONAL INSPECTION: THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. SCREENSHOT OF PASSING TEST IS ATTACHED. A REVIEW OF COMPLAINTS RELATED TO P/N 209063 SHOWS THE FAILURE TO OPERATE IN 19 OTHER COMPLAINTS WAS UNABLE TO BE DUPLICATED. THESE COMPLAINT INVESTIGATIONS ARE: (B)(4). ISSUES FOR P/N 209063 WILL BE COMPLETED THROUGH TREND REQUEST #900. CONCLUSIONS: FAILURE WAS NOT DUPLICATED. THE HANDPIECE WAS TESTED IN THE HANDPIECE TEST (QIP0243) AND PASSED. THE MOTOR SPUN AS EXPECTED DURING THE TEST. THE CABLE WAS AGITATED DURING THE TEST AND THE UNIT REMAINED FUNCTIONAL. 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 · 1

    PRIOR TO A TOTAL HIP ARTHROPLASTY PROCEDURE, THE MICS HANDPIECE WAS VERY WARM AND WAS GIVING A TEMPERATURE ERROR WHEN CHECKING MICS STATUS CHECK (DUE TO IT HAVING TO BE ONE-TRAYED). AFTER ALLOWING THE MICS TO COOL LONGER ABOUT 25 MINUTES WE RECHECKED THE MICS STATUS CHECK AND GOT A GREEN CODE. AFTER OPENING THE THA SOFTWARE A BURR STATUS MISMATCH CALL SERVICE ERROR CODE OCCURRED. THE SURGEON COMPLETED THE CASE MANUALLY.

    Description of Event or Problem · 1

    PRIOR TO A TOTAL HIP ARTHROPLASTY PROCEDURE, THE MICS HANDPIECE WAS VERY WARM AND WAS GIVING A TEMPERATURE ERROR WHEN CHECKING MICS STATUS CHECK (DUE TO IT HAVING TO BE ONE-TRAYED). AFTER ALLOWING THE MICS TO COOL LONGER ABOUT 25 MINUTES WE RECHECKED THE MICS STATUS CHECK AND GOT A GREEN CODE. AFTER OPENING THE THA SOFTWARE A BURR STATUS MISMATCH CALL SERVICE ERROR CODE OCCURRED. THE SURGEON COMPLETED THE CASE MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795700 HANDPIECE MICS STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization