BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4042630 · Received August 27, 2014

    Report

    Report Number
    2955842-2014-05283
    Event Type
    Other
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MGPS WAS RETURNED TO ISI AND EVALUATED. THE CUSTOMER REPORTED FAILURE MODE WAS REPLICATED WITH FAILURE ANALYSIS EVALUATION OF THE MGPS. THE MGPS WAS INSTALLED INTO AN IN-HOUSE PCA SYSTEM AND THE SYSTEM FAILED TO POWER UP. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PARTIAL NEPHRECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A POWER ISSUE WITH THE DA VINCI SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE DA VINCI SURGICAL SYSTEM WAS NOT POWERING UP. DURING THE EVENT, THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE TSE INSTRUCTED THE SURGICAL STAFF WITH EMERGENCY POWERING OFF AND RESTARTING THE DA VINCI SYSTEM. UPON RESTARTING, THE DA VINCI SYSTEM POWERED UP WITH THE PATIENT SIDE CART (PSC) RUNNING IN BATTERY MODE. THE TSE HAD THE SURGICAL STAFF CHECK THE POWER CORD CONNECTION WHICH WAS FOUND TO BE SECURE. DUE TO THE REPORTED SYSTEM POWER ISSUE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REPAIRED THE DA VINCI SYSTEM BY REPLACING THE MEDICAL GRADE POWER SUPPLY (MGPS) IN THE PSC. AFTER REPLACING THE MGPS, THE FSE TESTED THE SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE ROBOTICS COORDINATOR INDICATED THAT WHEN THE EVENT OCCURRED, THE PATIENT WAS UNDER ANESTHESIA AND THE SURGICAL STAFF WAS PREPARING THE DA VINCI SURGICAL SYSTEM. DUE TO THE SYSTEM POWER ISSUE, THE SURGEON MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE VIA OPEN SURGERY SINCE HE DID NOT WANT TO PERFORM THE SURGERY IN BATTERY MODE. THE OPEN SURGERY WAS SUCCESSFULLY COMPLETED AND NO POST-OPERATIVE COMPLICATIONS WERE REPORTED. THE ROBOTICS COORDINATOR ALSO STATED THE SYSTEM POWER ISSUE WAS RESOLVED AFTER THE FSE REPLACED THE MGPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519886 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other