BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1053087 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01037
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - THE INVESTIGATION CONDUCTED BY FIELD SVC ENGINEERING CONCLUDED THAT THE SYS FAULT EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A PT SIDE MANIPULATOR (PSM). THE PT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PT SIDE CART, THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYS WAS REPAIRED BY REPLACING THE AFFECTED PSM. RESULTS - THE SYS ALARM (SYS GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PT. THE #20008 SYS ERROR CODES APPEARED WHEN THE DAVINCI SAFETY SYS DETERMINED A DIFFERENTIAL CHANGE IN 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 AND EVALUATED. ENGINEERING FOUND THE CABLE INTACT, HOWEVER, IT DERAILED AT THE CARRIAGE END OF THE AXIS. ENGINEERING DETERMINED THAT DRAPE MATERIAL MAY GOTTEN CAUGHT IN BETWEEN THE PULLEY AND THE CABLE, CAUSING THE CABLE TO DERAIL FROM THE CARRIAGE PULLEY WHEN THE DRAPE WAS REMOVED. THE PSM WAS REPAIRED BY REPLACING THE TWO AXIS CABLES. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE THE CUSTOMER EXPERIENCED PERSISTANT #20008 SYSTEM ERROR CODES. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) DETERMINED THAT THE FAULT WAS RELATED TO A PT SIDE MANIPULATOR (PSM) ARM AND HAD THE CUSTOMER EXAMINE THE PSM. THE CUSTOMER FOUND A LOOSE CABLE. THE PT WAS UNDER ANESTHESIA AND PORT INCISIONS WERE MADE WHEN THE SURGEON DECIDED TO ABORT AND RESCHEDULE THE PLANNED SURGICAL PROCEDURE TO A LATER DATE.

    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 INSTRUMENTS| DA VINCI SURGICAL SYSTEM