BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST STAPLER 45 INSTRUMENT

    MDR report key: 4123758 · Received September 26, 2014

    Report

    Report Number
    2955842-2014-05402
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K113706
    Removal / Correction Number
    2955842-09-16-2014-008-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION CONFIRMED THAT THE INSTRUMENT JAWS WERE IN THE CLAMPED POSITION. THE JAWS DID NOT OPEN DURING MANUAL ROTATION OF THE INPUT DISKS OR WHEN AN IN-HOUSE MUT WAS USED AT THE BACKEND OF THE CLAMP COUPLING. UPON FURTHER INVESTIGATION THE CAM WING COMPONENT IN THE CLAMPING MECHANISM WAS FOUND TO BE BROKEN. WHILE THE MAJORITY OF THE CAM WING COMPONENT RETURNED TO THE UNCLAMP POSITION, A PIECE OF THE CAM WING COMPONENT REMAINED IN THE CLAMP POSITION PREVENTING THE JAWS OF THE STAPLER FROM OPENING. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JAWS ON THE ENDOWRIST STAPLER 45 INSTRUMENT WOULD NOT OPEN WHILE CLAMPED ONTO THE PATIENT'S TISSUE. AS A RESULT APPROXIMATELY 2MM OF THE PATIENT'S RECTAL TISSUE WAS REMOVED. THE SURGEON STATED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCE DUE TO THIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI RECTOVAGINAL FISTULA PROCEDURE, THE JAWS ON THE ENDOWRIST STAPLER 45 INSTRUMENT WOULD NOT OPEN AFTER IT WAS FIRED. THE SURGICAL STAFF ATTEMPTED TO OPEN THE GRIP USING THE MANUAL UNCLAMP TOOL (MUT); HOWEVER, THE JAWS ON THE INSTRUMENT WOULD NOT OPEN AND REMAINED IN THE CLAMPED POSITION. A SECOND MUT WAS USED; HOWEVER, THE ISSUE PERSISTED. UNABLE TO REMOVE THE INSTRUMENT, THE SURGEON MADE THE DECISION TO DISSECT A 2 MM PORTION OF THE PATIENT'S RECTAL TISSUE AROUND THE GRIP OF THE ENDOWRIST STAPLER 45 INSTRUMENT. ON (B)(4) 2014, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHOM WAS PRESENT DURING THE SURGICAL PROCEDURE STATED THAT THE INITIAL CLAMP FAILED AFTER THE ENDOWRIST STAPLER 45 INSTRUMENT WAS CLAMPING FOR APPROXIMATELY 10-15 SECONDS. THE ENDOWRIST STAPLER 45 INSTRUMENT UNCLAMPED SUCCESSFULLY MULTIPLE TIMES (THREE TIMES) DURING THE PROCEDURE, HOWEVER WHEN THE SURGEON COMPLETED FIRING THE INSTRUMENT, THE INSTRUMENT WOULD NOT UNCLAMP. THE CSR INDICATED THAT THE SURGEON USED AN UNSPECIFIED ENDOWRIST CAUTERY INSTRUMENT TO REMOVE THE ENDOWRIST STAPLER 45 INSTRUMENT FROM THE PATIENT'S TISSUE. THE SURGEON WAS ABLE TO COMPLETE THE ANASTOMOSIS, USING A NON ISI THIRD PARTY LAPAROSCOPIC STAPLER INSTRUMENT. THE OUTCOME OF THE PROCEDURE WAS NOT ALTERED AND THERE WAS NO HARM TO THE PATIENT. ON (B)(4) 2014, ISI CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON STATED HE HAD TO DISSECT ABOVE AND BELOW THE ENDOWRIST STAPLER 45 INSTRUMENT TO REMOVE IT FROM THE PATIENT'S TISSUE, EXTENDING THE STAPLE LINE APPROXIMATELY 2MM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE ADDITIONAL TISSUE REMOVED AND THE PATIENT IS RECOVERING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602659 ENDOWRIST STAPLER 45 INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410298-06 S10130917 069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention