BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI STANDARD SYSTEM

    MDR report key: 3306697 · Received August 26, 2013

    Report

    Report Number
    2955842-2013-03192
    Event Type
    Other
    Date Received
    August 26, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AS OF DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2013 CONFIRMED THE ALLEGED ERROR 212. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI STANDARD PROSTATECTOMY PROCEDURE THE SITE EXPERIENCED AN ERROR 212 AND DUE TO THE ERROR 212 MESSAGE THE SURGEON DECIDED TO CONVERT THE SURGICAL PROCEDURE TO OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI STANDARD PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED AN ERROR 212 ON THE MASTER TOOL MANIPULATOR RIGHT (MTMR) OF THE DA VINCI STANDARD SYSTEM ON (B)(6) 2013. DUE TO THE ALLEGED ERROR MESSAGE DURING THE DA VINCI SURGICAL PROCEDURE THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S STATUS POST- SURGERY. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). A SYSTEM ERROR CODE 212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. THE SITE CONTACTED INTUITIVE SURGICAL INC TECHNICAL SUPPORT ON (B)(6) 2013 ALLEGING THAT THE SITE HAD A RECOVERABLE 10025; HOWEVER, THE SYSTEM DID NOT START. AFTER RESTARTING SEVERAL TIMES THE ISSUE PERSISTED. ISI ORDERED REPLACEMENT PARTS FOR THE ALLEGED ERROR 212; HOWEVER, THE SURGEON DECIDED TO CANCEL THE ORDER SINCE THE SITE WAS THINKING ABOUT TRADING THE DA VINCI STANDARD. THE SITE HAS BEEN INSTRUCTED TO CONTACT INTUITIVE SURGICAL TECHNICAL SUPPORT IF THEY DECIDED TO HAVE THE DA VINCI STANDARD REPAIRED. INTUITIVE SURGICAL INC. ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416694 DA VINCI STANDARD SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. 1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES