BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USB CONVERTER- POLARIS SPECTRA CAMERA

    MDR report key: 5644304 · Received May 10, 2016

    Report

    Report Number
    3005985723-2016-00153
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 22, 2016
    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

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A 201148 USB CONVERTER- POLARIS SPECTRA CAMERA ON 200294 STAND ASSY, CAMERA AND SURGEON LCD S/N (B)(4). DEVICE EVALUATION AND RESULTS: THE DEVICE WAS INSPECTED PER (B)(4) AND THE 201148 USB CONVERTER- POLARIS SPECTRA CAMERA WAS REPLACED. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE USB CONVERTER- POLARIS SPECTRA CAMERA IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FOR SIMILAR COMPLAINTS ON 201148 USB CONVERTER- POLARIS SPECTRA CAMERA ON 200294 STAND ASSY, CAMERA AND SURGEON LCD S/N (B)(4) AND NO OTHER COMPLAINT WAS FOUND. TRACKING OF COMPLAINTS RELATED TO THE 201148 PART NUMBER WILL BE TRACKED THROUGH (B)(4). CONCLUSIONS: THE REPORTED EVENT OF A CONNECTION FAILURE BETWEEN THE NDI CAMERA (B)(4) AND THE GUIDANCE MODULE WAS CONFIRMED. THE INSPECTION LED TO THE REPLACEMENT OF THE 201148 USB CONVERTER- POLARIS SPECTRA CAMERA. DUE TO ITS AGE, THE 200590 NDI CAMERA WAS ALSO REPLACED. CORRECTIVE ACTION/PREVENTIVE ACTION: NO FURTHER ACTION IS REQUIRED; THE DEFECTIVE COMPONENTS HAVE BEEN REPLACED AND THERE IS ALSO NO INDICATION TO SUGGEST THIS WAS AN UNANTICIPATED HAZARD.

    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

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THERE WAS AN ISSUE WITH THE CAMERA. THE MAKOPLASTY SPECIALIST PERFORMED TROUBLESHOOTING ACTIVITIES BUT THE ISSUE COULD NOT BE RESOLVED AND HE CASE WAS CONVERTED TO MANUAL. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A MAKOPLASTY TOTAL HIP ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, THERE WAS AN ISSUE WITH THE CAMERA. THE MAKOPLASTY SPECIALIST PERFORMED TROUBLESHOOTING ACTIVITIES BUT THE ISSUE COULD NOT BE RESOLVED AND HE CASE WAS CONVERTED TO MANUAL. THE OUTCOME OF THE CASE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300091 USB CONVERTER- POLARIS SPECTRA CAMERA STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. CAM055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention