BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2884091 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-01411
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY AN ISI FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE SYSTEM ERROR CODE 25003 EXPERIENCED BY THE SITE. REVIEW OF THE SITE'S SYSTEM LOG BY THE FSE FOUND THAT SYSTEM ERROR CODE 25003 OCCURRED; HOWEVER, FUNCTIONAL TESTING OF THE SYSTEM FOUND NO ISSUES WITH THE SITE'S DA VINCI SI SURGICAL SYSTEM AND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATIONS. ADDITIONAL ENGINEERING REVIEW OF THE SITE'S SYSTEM LOG FOUND THAT SYSTEM ERROR CODE 25100 ALSO OCCURRED DURING THE SURGICAL PROCEDURE. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 25003 IS A SYMPATHETIC ERROR THAT MAY OCCUR IN CONJUNCTION WITH SYSTEM ERROR CODE 25100, WHEN THE SYSTEM DETECTS A DISRUPTION IN THE COMMUNICATION BETWEEN THE DIFFERENT COMPONENTS. THE FAULT MAY BE RESOLVED BY POWER CYCLING THE SYSTEM. ON (B)(4) 2012, ISI CONTACTED RN, (B)(6). (B)(6) INDICATED THAT NO PATIENT HARM, ADVERSE OUTCOME OR INJURY TO THE PATIENT OCCURRED AND THE PATIENT TOLERATED THE OPEN PROCEDURE WELL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI CYSTOCELE REPAIR PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 25003. THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ASSISTANCE. THE SITE INDICATED TO THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY PRESSED THE FAULT OVERRIDE BUTTON MULTIPLE TIMES; HOWEVER, THE ISSUE PERSISTED. THE TSE ASKED TO REVIEW THE SITE'S SYSTEM LOG; HOWEVER, THERE WAS NO CONNECTION TO THE SITE'S SYSTEM AVAILABLE. WHILE THE TSE WAS ATTEMPTING TO TROUBLESHOOT THE ISSUE WITH THE SURGICAL STAFF, THE TSE OVERHEARD THE SURGEON STATE THAT THE PROCEDURE WOULD BE CONVERTED TO OPEN SURGICAL TECHNIQUES. AT THIS TIME THE SITE INDICATED THAT THEY WOULD CALL BACK. APPROXIMATELY 30 MINUTES LATER, THE SITE CALLED ISI TECHNICAL SUPPORT BACK FOR ADDITIONAL TROUBLESHOOTING ASSISTANCE. THE SITE CONFIRMED THAT THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING TRADITIONAL OPEN SURGICAL TECHNIQUES. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND NO COMMUNICATION ERRORS ASSOCIATED WITH THE SYSTEM ERROR CODE 25003 AS STATED BY THE SITE. THE TSE EXPLAINED TO THE SITE THAT SYSTEM ERROR CODE 25003 IS A RECOVERABLE FAULT AND COULD HAVE BEEN RESOLVED BY PERFORMING A POWER CYCLE OF THE SYSTEM. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A60.P7

    Patients

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