BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1285934 · Received November 26, 2008

    Report

    Report Number
    2955842-2008-01414
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 26, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING FOUND THAT AN AXIS ON THE AFFECTED PATIENT SIDE MANIPULATOR (PSM) WAS ROTATED 360 DEGREES OUT OF RANGE, CAUSING THE PSM CABLE TO WRAP AROUND THE SETUP JOINT AND LIMITING MOVEMENT OF THE PSM. THE PATIENT SIDE MANIPULATOR (PSM) IS AN INSTRUMENT ARM LOCATED ON THE PATIENT'S SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE SYSTEM WAS REPAIRED BY PLACING THE PSM IN ITS PROPER POSITION AND TRAINING WAS PROVIDED TO THE SURGICAL STAFF REGARDING PROPER PSM PLACEMENT DURING CASE SETUP. AS OF (B) (6) 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 STARTING A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE, ONE OF THE SYSTEM PATIENT SIDE MANIPULATORS WOULD NOT MOVE INTO DOCKING POSITON. AN ISI TECHNICAL SUPPORT ENGINEER ATTEMPTED TO TROUBLESHOOT THE ISSUE VIA TELEPHONE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT HAD BEEN UNDER ANESTHESIA FOR 30 MINUTES WHEN THE SURGEON DECIDED TO ABORT THE PLANNED PROCEDURE AND RESCHEDULE IT FOR 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