BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3248309 · Received July 25, 2013

    Report

    Report Number
    2955842-2013-02752
    Event Type
    Other
    Date Received
    July 25, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) WAS UNABLE TO REPLICATE THE INSTRUMENT RECOGNITION ISSUE EXPERIENCED BY THE SITE. THE INSTRUMENTS USED DURING THE SURGICAL PROCEDURE WERE NOT AVAILABLE FOR THE FSE TO EVALUATE WITH THE SYSTEM. HOWEVER, DURING FUNCTIONAL TESTING OF THE SITE'S SYSTEM USING TEST INSTRUMENTS FOUND THAT THE SYSTEM FUNCTIONED WITHIN SPECIFICATION. THE FSE REVIEWED THE SITE'S SYSTEM LOGS AND FOUND THAT THE SITE EXPERIENCED SEVERAL OCCURRENCES OF ERROR CODE 31009 AND ALSO EXPERIENCED SYSTEM ERROR CODE 282. SYSTEM ERROR CODE 31009 OCCURS WHEN A TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. SYSTEM ERROR CODE OCCURS WHEN THE DA VINCI SURGICAL SYSTEM DETECTS THAT THE INSTALLED INSTRUMENT ON A PATIENT SIDE MANIPULATOR (PSM) IS INVALID. THE FSE CONCLUDED THAT THE STERILE ADAPTER USED DURING THE SURGICAL PROCEDURE WAS LIKELY NOT SEATED PROPERLY, THUS GENERATING SYSTEM ERROR CODE 31009. SYSTEM ERROR CODE 282 WAS GENERATED WHEN THE SITE INSTALLED AN INSTRUMENT THAT HAD NO REMAINING USES. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE NURSE MANAGER WHO REPORTED THE COMPLAINT. THE NURSE MANAGER INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. NO OTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED. ISI HAS CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. AS OF (B)(4) 2013 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, WHEN THE SITE INSTALLED DIFFERENT INSTRUMENTS ONTO A PATIENT SIDE MANIPULATOR (PSM) ARM, THE INSTRUMENTS WERE NOT RECOGNIZED. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. FOR TECHNICAL SUPPORT ASSISTANCE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING SEMI OPEN TECHNIQUES. REVIEW OF THE SITE'S SYSTEM LOGS SHOWED THAT SYSTEM ERROR CODE 31009 OCCURRED DURING THE SURGICAL PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349500 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P3

    Patients

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