BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA, POLARIS SPECTRA

    MDR report key: 9397064 · Received December 2, 2019

    Report

    Report Number
    3005985723-2019-00890
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 4, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MPS REPORTED CAMERA INTERMITTENT FAILURE TO PICK THE ARRAY SIGNAL. DEVICE INSPECTION: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 01/31/2017 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 17-01-0087, 17-01-0104, 17-01-0095, 17-01-0096. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO THE CAMERA, POLARIS SPECTRA, CATALOG #: 207335 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. FURTHER ACTION: NONE AT THIS TIME.

    Description of Event or Problem · 0

    CAMERA INTERMITTENT FAILURE TO PICK THE ARRAY SIGNAL UPDATE: "ALMOST 30 MINUTES DELAY IN SURGERY", THA. SURGERY GOT DELAYED BECAUSE OF POOR SENSATION OF CAMERA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    CAMERA INTERMITTENT FAILURE TO PICK THE ARRAY SIGNAL UPDATE: "ALMOST 30 MINUTES DELAY IN SURGERY", THA. SURGERY GOT DELAYED BECAUSE OF POOR SENSATION OF CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192307 CAMERA, POLARIS SPECTRA STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization