BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 929337 · Received October 4, 2007

    Report

    Report Number
    2955842-2007-00373
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    September 6, 2007
    Report Date
    October 5, 2007
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM ERROR CODE #23007 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED PSM. THE SYSTEM ALARM (SYSTEM GENERATED ERROR CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. AS OF 2007, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO BEGINNING THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED SYSTEM ERROR #23007, INDICATING THAT A SYSTEM PATIENT SIDE MANIPULATOR WAS NOT FREE TO MOVE DURING HOMING. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH 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 IS2000 A5.1P2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other