BEUDAMED
    FDA Adverse Event Other Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2851029 · Received November 17, 2012

    Report

    Report Number
    2955842-2012-00983
    Event Type
    Other
    Date Received
    November 17, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION PERFORMED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE CUSTOMER. WHEN THE FSE ARRIVED ON SITE TO EVALUATE THE SYSTEM, THE SITE WAS SETTING UP THE SYSTEM FOR THE NEXT PROCEDURE. THE INSTRUMENT AND STERILE ADAPTER WERE RETURNED FOR EVALUATION. ENGINEERING WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE DURING FUNCTIONAL TESTING OF THE INSTRUMENT ON AN IN-HOUSE IS3000 SYSTEM WITH AN IN-HOUSE STERILE ADAPTER. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTING. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND THERE WERE NO LOCKING ISSUED NOTED. THE INSTRUMENT WAS FULLY FUNCTIONAL. THE INSTRUMENT WAS ALSO TESTED ON AN IN-HOUSE IS3000 SYSTEM USING THE RETURNED STERILE ADAPTER AND TESTING SHOWED SOME INTERMITTENT ENGAGEMENT ISSUES WITH THE ADAPTER INPUT DISC; PREVENTING THE INSTRUMENT FROM MOVING INTUITIVELY; HOWEVER, INSTRUMENT LOCKING WAS NOT OBSERVED. THE FSE INDICATED THAT DURING HIS CONVERSATION WITH (B)(6), SHE INDICATED THAT THE SURGEON'S DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM; HOWEVER, THE SPECIFIC REASON WAS NOT PROVIDED. AT THIS TIME THE CAUSE OF THE BLEEDING EXPERIENCED BY THE PATIENT IS UNKNOWN. ISI HAS CONTACTED THE SITE TO VERIFY ADDITIONAL DETAILS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. AS OF (B)(4) 2012, 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 TENACULUM FORCEPS INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM #2 LOCKED, COULD NOT BE REMOVED AND THE LED INDICATOR ON THE PSM WAS GREEN AND YELLOW. PRIOR TO CONTACTING ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLESHOOTING ASSISTANCE THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES, DUE TO THE PATIENT BLEEDING. AFTER THE SYSTEM WAS UNDOCKED FROM THE PATIENT, THE TSE INSTRUCTED THE SITE TO RESTART THE SYSTEM AND THE SITE WAS ABLE TO REMOVE THE TENACULUM FORCEPS INSTRUMENT AND THE SYSTEM FUNCTIONED NORMALLY. NO OTHER DETAILS CONCERNING THE PATIENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420207-06 M10120105 124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES