BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 2080463 · Received May 6, 2011

    Report

    Report Number
    2955842-2011-00135
    Event Type
    Other
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE 212 WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) ARM. 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). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT THE DA VINCI IN A RECOVERABLE SAFE STATE. THE MTML WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING WAS ABLE TO CONFIRM THE OCCURRENCE OF SYSTEM ERROR CODE 212, THUS CONFIRMING THE REPORTED FAILURE MODE EXPERIENCED BY THE CUSTOMER. THE MTML MAIN HARNESS AND AXIS 2 MOTOR WERE REPLACED. 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 THE BEGINNING OF A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS STARTING TO DISSECT THE PATIENT'S BLADDER, THE SITE EXPERIENCED A SYSTEM ERROR CODE 212. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE RESTARTED THE SYSTEM AND THEN PERFORMED AN EMERGENCY POWER OFF (EPO) HOWEVER, THE SYSTEM ERROR CODE 212 REOCCURRED. THE PATIENT WAS UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN PLACED WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE TO A LATER DATE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

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