BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3272972 · Received August 8, 2013

    Report

    Report Number
    2955842-2013-02985
    Event Type
    Other
    Date Received
    August 8, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEERING (FSE) CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. THE FSE FOUND THAT THE CANNULA MOUNT ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 WAS BROKEN ON THE RIGHT WING AT THE LOWER HINGE THAT CONNECTS THE WING TO THE CLAMP. THE FSE WAS ABLE TO WORK THE HINGE CLOSED AND IT OPENED AND CLOSED FREELY. A TEST CANNULA WAS INSTALLED ONTO THE CANNULA MOUNT; HOWEVER, THE HOLDING FORCE WAS FOUND TO BE INADEQUATE. THE PSM CANNULA MOUNT ACCESSORY IS DESIGNED TO HOLD THE CANNULA SECURELY IN PLACE. THE CANNULA MOUNT ON PSM 1 WAS REPLACED TO REPAIR THE SYSTEM. THE CANNULA MOUNT ON PSM 2 WAS REPLACED AS A PRECAUTION. THE FSE PROVIDED RETRAINING TO THE NURSE MANAGER ON THE PROPER CLOSING TECHNIQUES OF THE CANNULA MOUNT. THE DA VINCI SURGEON SI SURGICAL SYSTEM USER MANUAL INSTRUCTIONS DEMONSTRATE HOW TO PROPERLY CLOSE THE CANNULA MOUNTS AND SPECIFICALLY STATES: SEAT THE CANNULA MOUNT MOLDING. MAKE SURE THE MOLDING SNAPS OVER THE CANNULA MOUNT THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN DUE TO A BROKEN CANNULA MOUNT. AS OF (B)(6), 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 SI HYSTERECTOMY PROCEDURE, THE CANNULA MOUNT ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 SNAPPED AND PIECES OF THE CANNULA MOUNT BROKE OFF. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2013 ISI CONTACTED THE SURGICAL TECHNICIAN WHO INITIALLY REPORTED THIS COMPLAINT. THE SURGICAL TECHNICIAN INDICATED THAT THE CANNULA MOUNT BROKE WHILE THE PATIENT SIDE ASSISTANT WAS DOCKING THE PSM TO THE PATIENT. DUE TO THE BROKEN CANNULA MOUNT, THE SURGEON MADE THE DECISION TO COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. IT IS UNKNOWN WHAT CAUSED THE CANNULA MOUNT TO BREAK. THE SURGICAL TECHNICIAN INDICATED THAT THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE OPEN PROCEDURE FINE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374316 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES