BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2091980 · Received May 18, 2011

    Report

    Report Number
    2955842-2011-00148
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K060391
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODES EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH TWO REMOTE ARM CONTROLLER (RAC) PCA BOARDS AND THE PATIENT CART CONTROLLER (PCC). THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY BOARDS (PCA) WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE PCC IS A BOARD EMBEDDED IN THE PATIENT CART THAT PROVIDES ALL USER INTERFACE, COMMUNICATIONS CONTROL, AND PATIENT CART MOTOR CONTROL FOR THE PATIENT SIDE SYSTEM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED RAC PCA BOARDS AND THE PCC BOARD. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE SYSTEM ERROR CODES REPORTED OCCUR WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES A HARDWARE FAULT REACTION LOGIC OCCURRING ON A LOCAL RAC. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE RAC3, RAC4, AND PCC WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION CONFIRMED FLUID CONTAMINATION AS REPORTED BY THE SITE. THE DA VINCI S SURGICAL SYSTEM USER MANUAL SPECIFICALLY STATES: CAUTION: EQUIPMENT IS NOT DESIGNATED FOR EXPOSURE TO LIQUIDS. CARE SHOULD BE TAKEN TO ENSURE LIQUIDS DO NOT FLOW INTO ELECTRONIC EQUIPMENT. ON (B)(4) 2011, FIELD SERVICE ENGINEERING HAD EXTENSIVE CONVERSATIONS WITH THE SITE REGARDING PROPER CLEANING OF THE DA VINCI S SYSTEM TO ELIMINATE FUTURE OCCURRENCES OF THIS EVENT. AS OF MAY 17, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 90 MINUTES INTO A DA VINCI S DIVERTICULUM SURGICAL PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 19 FOLLOWED BY SYSTEM ERROR CODE 45049. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) THE SITE RESTARTED THE SYSTEM, HOWEVER, UPON POWER UP SYSTEM ERROR CODE 281 APPEARED. AT THIS TIME, THE SITE STATED THAT A SMALL AMOUNT OF WATER HAD BEEN SPILLED ON THE BASE OF THE PATIENT SIDE CART. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGERY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYSTEM, INSTRUMENTS ANS ACCESSORIES