BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 2241809 · Received September 9, 2011

    Report

    Report Number
    2955842-2011-00293
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    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 THE SYSTEM ERROR CODES EXPERIENCED BY THE SITE WAS ASSOCIATED WITH A PATIENT SIDE MANIPULATOR (PSM). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART AND PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. SYSTEM ERROR CODES 20008 AND 21008 APPEARS WHEN THE DAVINCI SAFETY SYSTEM, 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. THE PSM WAS RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION OBSERVED THAT THE AXIS 7 CABLES HAD BECOME DERAILED FROM ITS PULLEYS. THE PSM WAS REPAIRED BY REPLACING THE CABLES. 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 DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF EXPERIENCED SYSTEM ERROR CODE 20008 AND 21008. THEY SITE ATTEMPTED TO TROUBLESHOOT THE ISSUE BY RESTARTING THE SYSTEM AND APPLYING EMERGENCY POWER OFF (EPO), HOWEVER, THE SYSTEM ERROR CODE PERSISTED. AT THIS TIME, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A TRADITIONAL OPEN SURGICAL TECHNIQUES. NO PATIENT HARM 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 65 YR Other DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES