BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1531172 · Received November 6, 2009

    Report

    Report Number
    2955842-2009-00363
    Event Type
    Injury
    Date Received
    November 6, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 7, 2009
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K070684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING (FSE) CONSISTED OF REVIEWING SYSTEM ERROR LOGS AND PERFORMING FUNCTIONAL TEST. THE FSE'S REVIEW OF SYSTEM ERROR LOGS DID NOT REVEAL ANY SYSTEM ERRORS AND THE SYSTEM FUNCTIONED AS INTENDED WITH NO ISSUES. THE USER MESSAGE "LIGHTEN GRIP" APPEARS WHEN THE SYSTEM ATTEMPTS TO DRIVE THE MASTER TO THE DESIRED ALIGNMENT POSITION BUT THE MASTER CANNOT REACH THIS POSITON. LIGHTENING THE HOLD OF THE MTM WILL ALLOW THE USER TO CONTINUE. THE MASTER ALIGNMENT IS DESIGNED TO ENSURE THE MASTER GRIPS ARE APPROPRIATELY POSITIONED RELATIVE TO THE TIPS OF THE INSTRUMENTS IN THE HIGH DEFINITION STEREO VIEWER. MASTER ALIGNMENT HAPPENS IN THE FOLLOWING CONDITIONS: WHENEVER A NEW INSTRUMENT IS INSTALLED, WHENEVER A NEW SCOPE ANGLE IS SELECTED, WHEN THE PATIENT CART OPERATOR MOVES THE INSTRUMENT OR CAMERA ARMS, INSTRUMENT ARM SWAPPING. SINCE THIS EVENT, THE ISI CLINICAL SALES REPRESENTATIVE HAS PROVIDED ADDITIONAL TRAINING TO THE CONSOLE SURGEON REGARDING APPROPRIATE TROUBLESHOOTING OF THIS USER MESSAGE. AS OF 2009, THE HOSPITAL HAS CONTINUED TO USE THE SYSTEM WITH NO REPORTED RECURRENCES OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.

    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 A5.1P.8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ELECTROSURGICAL UNIT| DA VINCI S SURGICAL INSTRUMENTS| ACCESSORIES