BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHERNET CAT5 TO FIBER CONV.

    MDR report key: 6484908 · Received April 12, 2017

    Report

    Report Number
    3005985723-2017-00174
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 7, 2017
    Report Date
    May 8, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    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

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO CORRECT THE CATALOG #. REPORTED EVENT: ETHERNET CAT5 TO FIBER CONV ROBOT CONNECTION ERROR. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE ETHERNET CAT5 TO FIBER CONV EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH ROB343 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED WITH NO NOTES OR COMMENTS. 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 THE ETHERNET CAT5 TO FIBER CONV ROBOT CONNECTION ERROR FAILURE OF P/N: 200933. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REFERENCED SERIAL NUMBER. CONCLUSIONS: THE ETHERNET CAT5 TO FIBER CONV REPORTED EVENT WAS CONFIRMED. 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 · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE MPS REPORTED A ROBOT CONNECTION ERROR. THE FIRST CASE WAS STARTED USING THE ROBOT BUT COMPLETED MANUALLY AND ALL OTHER CASES WERE COMPLETED USING THE BYPASS.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A TOTAL HIP ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE MPS REPORTED A ROBOT CONNECTION ERROR. THE FIRST CASE WAS STARTED USING THE ROBOT BUT COMPLETED MANUALLY AND ALL OTHER CASES WERE COMPLETED USING THE BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266340 ETHERNET CAT5 TO FIBER CONV. STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. ROB343

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization