BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6703505 · Received July 11, 2017

    Report

    Report Number
    3005985723-2017-00298
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 16, 2017
    Report Date
    August 31, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    (B)(6) "REPORTED EVENT: IT WAS REPORTED THAT THE HANDPIECE DID NOT WORK. ISSUE WAS NOTICED DURING CASE, THEREFOR THERE WAS A 15 MINUTE CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08U3 AND ALL WERE ACCEPTED INTO FINAL STOCK ON 12/21/16. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K08U3, P/N 209063 SHOWS 1 OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT INVESTIGATIONS ARE: (B)(4) THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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." THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    MPS: (B)(6) REPORTED THAT STAFF COULD NOT REGISTER THE SAW BLADE ON THE MICS DURING THE TOTAL KNEE CASE. DOCTOR COMPLETED CASE MANUALLY. PKA 1.0, CRISIS 2.13.2, MGO 1.1.8, UTILITIES 1.10. COMPLETED ALL OF THE PM CHECKS WITH NO ISSUES. ALL ARM CALIBRATIONS ARE ACCURATE. I COULD NOT FIND ANY ISSUES WITH THE ROBOT OPERATIONS. THE MPS ((B)(6)) WAS ON SIGHT WHILE I WAS CHECKING THE ROBOT. ALSO COMMUNICATED WITH THE DOCTOR THAT ALL THE CALIBRATION SETTING WERE ACCURATE. UPDATE PER MPS: <15 MIN DELAY.

    Description of Event or Problem · 1

    MPS: (B)(6) REPORTED THAT STAFF COULD NOT REGISTER THE SAW BLADE ON THE MICS DURING THE TOTAL KNEE CASE. DOCTOR COMPLETED CASE MANUALLY. PKA 1.0, CRISIS 2.13.2, MGO 1.1.8, UTILITIES 1.10. COMPLETED ALL OF THE PM CHECKS WITH NO ISSUES. ALL ARM CALIBRATIONS ARE ACCURATE. I COULD NOT FIND ANY ISSUES WITH THE ROBOT OPERATIONS. THE MPS (ANDREW HACKETT) WAS ON SIGHT WHILE I WAS CHECKING THE ROBOT. ALSO COMMUNICATED WITH THE DOCTOR THAT ALL THE CALIBRATION SETTING WERE ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481188 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42031116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization