BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAVINCI SI SURGICAL SYSTEM

    MDR report key: 3032641 · Received March 29, 2013

    Report

    Report Number
    2955842-2013-01045
    Event Type
    Other
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) AND REVIEW OF THE SYSTEM ERROR LOGS DETERMINED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE DOUBLE CAMERA CONTROLLER (DOCO). THE DOCO REFERS TO THE TWO CAMERA CONTROLLER UNITS (CCU) THAT CONTROL THE ACQUISITION AND PROCESSING OF THE IMAGE FROM THE CAMERA. ONE CCU IS ASSIGNED TO THE SURGEON'S RIGHT SID IMAGE (RIGHT CCU) AND ONE TO HIS LEFT (LEFT CCU). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED DOCO. AS OF (B)(4) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGEON EXPERIENCED A YELLOW AND GREEN IMAGE THROUGH THE RIGHT EYE OF THE HIGH RESOLUTION STEREO VIEWER ON THE SURGEON SIDE CART (SSC). THE SITE INSTALLED THEIR BACKUP CAMERA CABLE; HOWEVER, THE IMAGE THROUGH THE RIGHT EYE WENT BLANK, WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE) THE SITE CHECKED THE BLUE FIBER CABLE CONNECTION TO THE SSC. THE SITE FOUND NO ISSUES. WITH THE ASSISTANCE OF THE TSE THE SITE REPLACED THE BACKUP CAMERA CABLE WITH THE ORIGINAL CAMERA CABLE; HOWEVER, THE ISSUE PERSISTED. THE PATIENT HAD BEEN ADMINISTERED ANESTHESIA WHEN THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE AND RESCHEDULE IT FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130046 DAVINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, NAY NAY INTUITIVE SURGICAL, INC. IS3000 A60.P3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INSTRUMENTS AND ACCESSORIES| DA VINCI SI SURG. SYS.