BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3972721 · Received August 1, 2014

    Report

    Report Number
    2955842-2014-04653
    Event Type
    Other
    Date Received
    August 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISI CORE WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR INVESTIGATION WITH THE FOLLOWING FINDINGS: THE CORE WAS RETURNED WITH THE INCORRECT CONFIGURATION. THE PERSONALITY MODULE ENERGY DEVICE (PMED) WAS REPLACED IN THE FIELD WHICH DID NOT MATCH THE CORE CELEBRATION. THE REPORTED CUSTOMER FAILURE MODE WAS REPLICATED. FAILURE ANALYSIS (FA) APPLIED POWER TO THE CORE AND NO LIGHT EMITTING DIODES (LEDS) TURNED ON, ONLY THE FANS POWERED ON. THERE WAS NO POWER ON ANY OF THE BOARDS EXCEPT THE INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD) WHICH HAD A FLASHING RED LIGHT. THE RED LED LIGHT IS FOR A SUPPLY FAULT, SO FAILURE ANALYSIS DISCONNECTED THE CONTROL CABLE TO THE POWER SUPPLIES AND MEASURED THE VOLTAGE OF BOTH SUPPLIES AND THEY BOTH TESTED AT 12.05V. AFTER FURTHER TROUBLESHOOTING, FA FOUND THAT THE FAULT WOULD GO AWAY WHEN THE PERSONALITY MODULE VIDEO ACQUISITION (PMVA) MODULE WAS REMOVED FROM THE CORE. FA REMOVED THE PMVA AND APPLIED POWER TO IT AND SMOKE CAME OUT FROM THE VBR BOARD. FA REPLACED THE VIDEO BRANCH BOARD (VBR) FROM THE PMVA AND WAS ABLE TO POWER UP THE CORE. A COMPONENT ON THE POWER MODULE U33 CAUSED THE SMOKE ON THE OLD VBR BOARD.

    Additional Manufacturer Narrative · 1

    THE SYSTEM CORE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE CORE IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO AN OPEN SURGICAL TECHNIQUE DUE TO THE SYSTEM SHUTTING DOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE SYSTEM SHUT DOWN. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO AN OPEN SURGICAL PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE THE SAME DAY AND REPLACED THE CORE OF THE SYSTEM. THE CORE IS BEING REQUESTED BACK FOR FURTHER INVESTIGATION. ON (B)(4) 2014, ISI OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM AN ISI FSE. THE SYSTEM WAS TESTED PRIOR TO USE AND NO SYSTEM MALFUNCTION WAS OBSERVED. APPROXIMATELY 20 MINUTES AFTER THE FIRST INCISION WAS MADE, THE LEDS ON ALL THE ARMS BECAME RED, THERE WAS NO LIGHT SOURCE, AND THE SYSTEM SHUT DOWN. DUE TO THE REPORTED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO AN OPEN SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED ABOUT THE PATIENT'S CURRENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450744 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R