BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1080670 · Received July 21, 2008

    Report

    Report Number
    2955842-2008-01153
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 18, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY AN ISI REPRESENTATIVE CONFIRMED THAT THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) CANNULA MOUNT WAS BROKEN. THE ECM CANNULA MOUNT HOLDS THE CANNULA SECURELY IN PLACE WHILE THE CAMERA IS DELIVERED THROUGH THE CANNULA. THE CANNULA PROVIDES THE PORT THROUGH THE BODY WALL OF THE PT, THROUGH WHICH THE ENDOSCOPE IS INSERTED. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM CANNULA CAMERA MOUNT. 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 WHILE SETTING UP THE DA VINCI S SURGICAL SYSTEM FOR A HYSTERECTOMY PROCEDURE, THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) CANNULA CAMERA MOUNT BROKE OFF. THE PT WAS UNDER ANESTHESIA FOR APPROXIMATELY 30 MINUTES AND THE PORT INCISIONS HAD BEEN CREATED WHEN THE SITE DECIDED TO CONVERT TO LAPAROSCOPIC SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY. NO PT 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 INTUITIVE SURGICAL, INC. IS2000 A5.1P4

    Patients

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