BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1053086 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01002
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    February 26, 2008
    Report Date
    May 16, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY ISI FIELD SERVICE ENGINEERING FOUND A SMALL CUT ON ONE OF THE LEADS OF THE CAMERA CABLE AND THEREFORE CONCLUDED THAT THE UNSTABLE VIEW EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE CAMERA CABLE. THE CAMERA CABLE ATTACHES THE CAMERA TO THE CAMERA CONTROL UNIT (CCU), FOCUS CONTROL UNIT (FCU), AND THE VISION CART. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CAMERA CABLE. AS OF 2008, 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 A DA VINCI S SURGICAL PROCEDURE, THE SYSTEM SURGEON SIDE CONSOLE (SSC) VIEW WAS UNSTABLE AND 3D CALIBRATION COULD NOT BE PERFORMED. THE PATIENT WAS UNDER ANESTHESIA, HOWEVER, NO SURGICAL TASKS HAD BEEN PERFORMED WHEN THE SURGEON DECIDED TO POSTPONE THE PROCEDURE. THE PROCEDURE WAS COMPLETED THE FOLLOWING DAY WITH THE DA VINCI S SURGICAL SYSTEM. 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 A5.1P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INSTRUMENTS| ACCESSORIES| DA VINCI S SURGICAL SYSTEM