BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3119140 · Received May 19, 2013

    Report

    Report Number
    2955842-2013-01751
    Event Type
    Other
    Date Received
    May 19, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER, DETERMINED THAT THE ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE BRAKE WITHIN THE PATIENT SIDE MANIPULATOR (PSM) ARM 2. 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 PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE FAILURE MODE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE PSM ON AN IN-HOUSE IS3000 TEST SYSTEM FOUND THAT THE PSM PASSED FRICTION AND BRAKE TESTING. ENGINEERING RESTARTED THE TEST SYSTEM IN NORMAL MODE AND PERFORMED MULTIPLE POWER CYCLES WHILE MOVING THE PSM IN DIFFERENT POSITIONS. NO BRAKE FAILURE OCCURRED AND THERE WERE NO SYSTEM ERRORS GENERATED. THE PSM ALSO PASSED AN ADVANCED BRAKE TEST. AS A PRECAUTION, AXIS 1 AND AXIS 2 OF THE PSM WAS REPLACED. ENGINEERING EVALUATION ALSO FOUND THAT THE AXIS 2 PRODUCED A LOW READING. THE AXIS 2 HARMONIC DRIVE WAS REPLACED TO REPAIR THE AFFECTED AXIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI DISTAL PANCREATECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 2 ARM INSERTION AXIS APPEARED TO MOVE DOWNWARD. REPORTEDLY, THE SYSTEM WAS DOCKED TO THE PATIENT AND A HARMONIC SHEARS INSTRUMENT WAS INSTALLED ON THE PSM WHEN THE ISSUE OCCURRED. NO PATIENT HARM OR INJURY WAS REPORTED. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220914 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURG SYS, INSTRUMENTS & ACCESSORIES.