BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CORD, TGS SYSTEM V2, 20' LG

    MDR report key: 9165866 · Received October 8, 2019

    Report

    Report Number
    3005985723-2019-00720
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    October 3, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, POWER CORD, TGS SYSTEM V2, 20' LG, CATALOG #207010, WAS REPORTED TO SPARK AND SMOKE RANDOMLY. 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 7/27/2011 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 11-07-0027, 11-07-0036, 11-07- 0039, 11-07-0016, 11-07-0079, 11-07-0104, 10-11-0042, 11-06-0129, 11-06-0099, 11-06-0108, 11-06-0123. 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 POWER CORD, TGS SYSTEM V2, 20' LG, CATALOG #: 207010 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE POWER CORD STARTED TO SPARK AND THEN STARTED SMOKING RANDOMLY AT THE END OF THE CASE WHEN WE WERE CEMENTING. CASE TYPE: PKA.

    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

    THE POWER CORD STARTED TO SPARK AND THEN STARTED SMOKING RANDOMLY AT THE END OF THE CASE WHEN WE WERE CEMENTING. CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960303 POWER CORD, TGS SYSTEM V2, 20' LG STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization