BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1558280 · Received December 4, 2009

    Report

    Report Number
    2955842-2009-00396
    Event Type
    Other
    Date Received
    December 4, 2009
    Date of Event
    November 5, 2009
    Report Date
    November 5, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDING THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A LOOSE SET SCREW LOCATED ON THE RIGHT MASTER TOOL MANIPULATOR (MTMR) GIMBAL. THE MTMR GIMBAL IS A SUBSECTION OF THE COMPLETE MTM ARM, CONSISTING OF LINKS ASSOCIATED WITH THE FIVE AXES OF MOTION CLOSEST TO THE SURGEON'S HAND. THESE AXES MEASURE THE ORIENTATION OF THE MTM HANDLE AND THE MTM GRIP ANGLE. THE GIMBAL IS SEPARATED FROM THE REST OF THE MTM BY REMOVING THE PLATFORM LINK FROM THE FOREARM LINK. THE SYSTEM WAS REPAIRED BY REPLACING THE RIGHT MTM GIMBAL. THE MTMR GIMBAL WAS RETURNED TO ISI FOR EVALUATION. ENGINEERING DETERMINED THAT A MISALIGNMENT IN THE ASSEMBLY OF THE MTMR GIMBAL CAUSED THE SET SCREW TO BECOME LOOSE. AS OF (B)(4), 2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE RIGHT MASTER TOOL MANIPULATOR (MTMR) GIMBAL CAME APART DUE TO A LOOSE SCREW. THE SURGICAL PROCEDURE HAD BEEN IN PROGRESS FOR 30 MINUTES WHEN THE SURGEON DECIDED TO ABORT, CLOSE THE PATIENT AND RESCHEDULE THE PROCEDURE FOR A LATER DATE. 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 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other