BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2132968 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00184
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE 16 WAS ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM) SETUP-JOINT AXIS. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SETUP-JOINT (SUJ) IS A NON-MOTORIZED SUPPORT ARM WHICH HOLDS A PATIENT SIDE MANIPULATOR (PSM) DURING SURGERY. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED SUJ. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 16 IS REPORTED BY THE SOFTWARE TO DENOTE COMMUNICATION FAULTS IN THE LOW VOLTAGE DIFFERENTIAL SIGNAL CARRYING INFORMATION ABOUT THE PSM. UPON DETERMINING THIS CONDITION, THE SYSTEM RECORDS THE FAULT AND TRANSITIONS TO A SAFE STATE. THE SUJ WAS RETURNED FOR FAILURE ANALYSIS EVALUATION. ENGINEERING WAS ABLE TO REPLICATE THE REPORTED FAILURE AND REPLACED ALL INTERNAL ELECTRICAL CABLES TO ADDRESS THE SYSTEM ERROR CODES EXPERIENCED BY THE CUSTOMER. AS OF (B)(6) 2011, 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 THE SITE EXPERIENCED SYSTEM ERROR CODE 16 AND LOST POWER ON A PATIENT SIDE MANIPULATOR (PSM) ARM. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER THE SITE RESTARTED THE SYSTEM AND TRIED TO MANUALLY REPOSITION THE PSM, HOWEVER THE PSM DID NOT REGAIN POWER. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. 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 A6.0P6

    Patients

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