BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREEN ENDOWRIST STAPLER 45 RELOAD

    MDR report key: 3945204 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04409
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K113706
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GREEN STAPLER RELOAD WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE BLADE ON THE STAPLER RELOAD WAS EXPOSED. REMOVAL OF THE METAL CASING FOUND NO SIGNIFICANT OBSTRUCTING DEBRIS. NO OTHER DAMAGE FOUND. REVIEW OF THE SITE'S SYSTEM LOGS SHOWED THAT THE ERROR CODE 32075 OCCURRED ON THE SEVENTH FIRE. THE PEAK TORQUE RECORDED DURING THE FAILURE SHOWED THAT THE PEAK TORQUE LIMIT WAS NEAR THE MAXIMUM TORQUE LIMIT. THE BLADE REACHED 70 PERCENT OF THE EXPECTED TRAVEL BEFORE THE ERROR WAS GENERATED. THERE WERE NO OTHER ERRORS FOUND RELATED TO HOMING/CLAMPING AND/OR FIRING DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI RIGHT COLECTOMY PROCEDURE, THE PATIENT HAD TO UNDERGO AN ADDITIONAL SURGICAL PROCEDURE DUE TO AN ANASTOMOTIC LEAK. HOWEVER, AT THIS TIME, THE DEFINITIVE CAUSE OF THE ANASTOMOTIC LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DA VINCI COLECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD AN ANASTOMOTIC LEAK. REPORTEDLY, DURING THE SURGICAL PROCEDURE, WHILE THE ENDOWRIST STAPLER 45 INSTRUMENT WITH A GREEN STAPLER RELOAD INSTALLED WAS BEING FIRED, THE ERROR MESSAGE INCOMPLETE STAPLER FIRE, BLADE EXPOSED WAS OBSERVED HALFWAY THROUGH THE FIRE. A REPLACEMENT STAPLER RELOAD WAS USED TO COMPLETE THE STAPLE LINE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT THAT THE PATIENT EXPERIENCED ANY INTRA OPERATIVE INJURY DURING THE SURGICAL PROCEDURE. ON (B)(6)2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) FOR THE HOSPITAL. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE CASE. THE CSR INDICATED THAT THE SURGEON COMPLETED THE STAPLE LINE USING A REPLACEMENT STAPLER RELOAD. THE SURGEON PERFORMED A VISUAL INSPECTION OF THE ANASTOMOSED TISSUE AND THE CLOSURE WAS FOUND TO BE ADEQUATE. ON (B)(6) 2014, THE ISI CSR CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT. ACCORDING TO THE CSR HE WAS TOLD BY THE SURGEON THAT ON (B)(6) 2014, THE PATIENT PRESENTED SYMPTOMS OF AN ANASTOMOTIC LEAK. THE PATIENT UNDERWENT RE-OPERATION AND IT WAS DISCOVERED THAT THE PATIENT WAS LEAKING FROM THE STAPLE LINE THAT CLOSED THE COMMON OPENING AND THE STAPLE LINE WAS FOUND TO HAVE PARTIALLY FORMED STAPLES AROUND THE AREA OF LEAKAGE. RESECTION AND ANASTOMOSIS WERE PERFORMED TO REPAIR THE AFFECTED AREA. ACCORDING TO THE SURGEON, HE USED 4 FIRES TO CREATE THE STAPLE LINE. HE INDICATED THAT IT IS HIS BELIEF THAT THE MISFIRED STAPLER RELOAD CONTRIBUTED TO THE ANASTOMOTIC LEAK EXPERIENCED BY THE PATIENT, DUE TO THE PARTIALLY FORMED STAPLES FOUND IN THE AREA WERE THE ANASTOMOTIC LEAK OCCURRED. THE SURGEON INDICATED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL TO REHABILITATION ON (B)(6) 2014. THE PATIENT CURRENTLY HAS A TEMPORARY COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422617 GREEN ENDOWRIST STAPLER 45 RELOAD ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 41445G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R