BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1982927 · Received February 9, 2011

    Report

    Report Number
    2955842-2011-00043
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT SYSTEM ERROR CODE 23013 AND 23008 WERE ASSOCIATED PATIENT SIDE MANIPULATOR (PSM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23013 AND 23008 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THAT THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT DAVINCI IN A RECOVERABLE SAFE STATE. THE PSM WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DETERMINED THAT THE POTENTIOMETER HAD MALFUNCTIONED ON THE PSM, THUS GENERATING THE SYSTEM ERROR CODES EXPERIENCED BY THE CUSTOMER. AS OF (B)(4) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 23013 AND 23008 WHEN ATTEMPTING TO ATTACH THE STERILE ADAPTER TO THE PATIENT SIDE MANIPULATOR (PSM). AN ISI TECHNICAL SUPPORT ENGINEER (TSE) ATTEMPTED TO ASSIST THE SITE TO OVERRIDE THE SYSTEM ERROR; HOWEVER, THE SITE MADE THE DECISION TO ABORT THE PLANNED PROCEDURE. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME THE DECISION WAS MADE NOT TO CONTINUE WITH THE PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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, ACCESSORIES AND ES