BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0

    MDR report key: 7447593 · Received April 20, 2018

    Report

    Report Number
    3005985723-2018-00254
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: MPS REPORTED VOLTAGE ERROR WITH THE MICS. DEVICE EVALUATION AND RESULTS: PER GSP 164906: REPLACED COMMUTAION ASSEMBLY(209954). TESTED MICS #4203569,4203550,4201609 AND 4200617 WITH PASSING FINAL TEST RESULTS. PERFORMED ALL PRE-SURGERY TESTING WITH PASSING FINAL RESULTS. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 11/04/16 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 16-10-0025, QT 16-10-0013, QT 16-10-0012. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209954, SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: SYSTEM READY FOR CLINICAL USE. 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 · 0

    UPON ENTERING BONE PREP, THE MICS HAND PIECE WORKED FINE WHEN PRESSING THE TRIGGER TO ALIGN THE ARM INTO THE HAPTIC FIELD. AFTER RELEASING THE TRIGGER AND ATTEMPTING TO CUT, THERE WAS NO POWER TO THE MICS. AFTER VARIOUS TROUBLESHOOTING STEPS OF RESETTING THE CUTTER, UNPLUG/REPLUG, RESTARTING ARM SOFTWARE, THERE WAS STILL NO POWER. WHEN WE PERFORMED A MICS STATUS CHECK, WE RECEIVED AN ERROR STATING LOW BUS VOLTAGE FAULT. WE TRIED TWO OTHER MICS'S AND A FULL SYSTEM SHUT DOWN, BUT NOTHING ALWAYS RECEIVED THE SAME STATUS AND COULD NOT CUT. UPON COMMUNICATING WITH THE MAKO HOTLINE, I WAS INFORMED THAT THE ISSUE WAS WITH AN INTERNAL COMPONENT AND THERE WAS NOTHING THAT COULD BE DONE. THE PROCEDURE WAS COMPLETED USING TRADITIONAL MANUAL INSTRUMENTATION. TKA CASE DELAYED 10 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

    UPON ENTERING BONE PREP, THE MICS HAND PIECE WORKED FINE WHEN PRESSING THE TRIGGER TO ALIGN THE ARM INTO THE HAPTIC FIELD. AFTER RELEASING THE TRIGGER AND ATTEMPTING TO CUT, THERE WAS NO POWER TO THE MICS. AFTER VARIOUS TROUBLESHOOTING STEPS OF RESETTING THE CUTTER, UNPLUG/REPLUG, RESTARTING ARM SOFTWARE, THERE WAS STILL NO POWER. WHEN WE PERFORMED A MICS STATUS CHECK, WE RECEIVED AN ERROR STATING LOW BUS VOLTAGE FAULT. WE TRIED TWO OTHER MICS'S AND A FULL SYSTEM SHUT DOWN, BUT NOTHING ALWAYS RECEIVED THE SAME STATUS AND COULD NOT CUT. UPON COMMUNICATING WITH THE MAKO HOTLINE, I WAS INFORMED THAT THE ISSUE WAS WITH AN INTERNAL COMPONENT AND THERE WAS NOTHING THAT COULD BE DONE. THE PROCEDURE WAS COMPLETED USING TRADITIONAL MANUAL INSTRUMENTATION. TKA CASE DELAYED 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290460 CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0 STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization