BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CORD, TGS SYSTEM V2, 20' LG

    MDR report key: 8633592 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00381
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: THE MPS REPORTED BROKEN GROUND ON POWER CORD. DEVICE INSPECTION: VISUAL INSPECTION SHOWS DAMAGE TO THE 739 NEMA 5/15 HOSPITAL GRADE SUPPLY END PLUG. THE GROUND PRONG BROKE OFF FROM THE PLUG. SEE ATTACHMENT FOR IMAGE OF THE DEFECTIVE DEVICE. DEVICE HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 07/31/2013 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: QT 13-06-0040, 13-07-0047, 13-07-0051, 13-07-0038, 13-07-0003. 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 38 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE COMPLAINTS ARE: (B)(4). CONCLUSIONS: THE POWER CORD WAS REPLACED AND ALL SYSTEM TESTING WAS SUCCESSFULLY COMPLETED. THE SYSTEM IS READY FOR CLINICAL USE. FURTHER ACTION: NONE AT THIS TIME.

    Description of Event or Problem · 0

    WHEN PLUGGING THE ROBOT IN BEFORE THE CASE IT WAS NOTICED THAT THE GROUND PRONG HAD BROKEN OFF FROM THE POWER CORD IN THE OUTLET WHERE THE ROBOT CHARGES OVERNIGHT. DUE TO THE ELECTRICAL SAFETY HAZARD THE CASE WAS DELAYED WHILE A TEMPORARY REPLACEMENT CORD WAS BROUGHT UP FROM ANOTHER HOSPITAL. CASE TYPE: PKA. SURGICAL DELAY: 30-60 MINUTES. UPDATE: "THE PATIENT DID HAVE A SPINAL WHEN THIS ISSUE WAS DISCOVERED BUT WE WERE ABLE TO GET A REPLACEMENT CORD IN TIME TO COMPLETE THE CASE WITH NO COMPLICATIONS.".

    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

    WHEN PLUGGING THE ROBOT IN BEFORE THE CASE IT WAS NOTICED THAT THE GROUND PRONG HAD BROKEN OFF FROM THE POWER CORD IN THE OUTLET WHERE THE ROBOT CHARGES OVERNIGHT. DUE TO THE ELECTRICAL SAFETY HAZARD THE CASE WAS DELAYED WHILE A TEMPORARY REPLACEMENT CORD WAS BROUGHT UP FROM ANOTHER HOSPITAL. CASE TYPE: PKA. SURGICAL DELAY: 30-60 MINUTES. UPDATE: "THE PATIENT DID HAVE A SPINAL WHEN THIS ISSUE WAS DISCOVERED BUT WE WERE ABLE TO GET A REPLACEMENT CORD IN TIME TO COMPLETE THE CASE WITH NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424663 POWER CORD, TGS SYSTEM V2, 20' LG STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization