BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST STAPLER 45 RELOAD

    MDR report key: 5698028 · Received June 3, 2016

    Report

    Report Number
    2955842-2016-00416
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    October 5, 2015
    Report Date
    May 5, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENDOWRIST STAPLER 45 RELOAD AND ENDOWRIST STAPLER 45 INSTRUMENT HAVE NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION, THEREFORE, THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THE REPORTED EVENT. ISI PERFORMED A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE. REVIEW OF THE PROCEDURE DATA FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THERE WERE 3 FIRES FROM THE INSTRUMENT. THERE WERE NO INCOMPLETE CLAMPS AND ALL OF THE STAPLER RELOADS FIRED FROM THE INSTRUMENT WERE SUCCESSFULLY FIRED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI ASSISTED COLORECTAL PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE LEAK, REQUIRING THE PATIENT TO UNDERGO A SUBSEQUENT SURGICAL PROCEDURE TO REPAIR THE LEAK. DURING THE SURGICAL PROCEDURE, THERE WERE TWO SEPARATE STAPLER INSTRUMENTS USED TO MAKE THE ANASTOMOSIS AND ONLY ONE OF THEM WAS AN ISI PRODUCT. IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE PATIENT'S POST OPERATIVE COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI ASSISTED COLECTOMY PROCEDURE WITH FIREFLY TECHNOLOGY, PERFORMED ON (B)(6) 2015 THE PATIENT EXPERIENCED A POST-OPERATIVE LEAK. THE PATIENT UNDERWENT A SUBSEQUENT SURGICAL PROCEDURE TO REPAIR THE LEAK. REPORTEDLY, THE PRIMARY DA VINCI ASSISTED SURGICAL PROCEDURE WENT WELL. THE PATIENT HAD NOT UNDERGONE ANY PRIOR PROCEDURES IN THE SURGICAL AREA AND THERE WERE NO ISSUES WITH THE PATIENT'S TISSUE. THE PATIENT HAD NOT UNDERGONE ANY RADIATION TREATMENTS. DURING THE PROCEDURE THE SURGEON DID NOT NOTICE ANY TENSION ON THE PATIENT'S ILEORECTAL ANASTOMOSIS AND THE EEA DONUTS WERE OBSERVED TO BE INTACT. PNEUMO TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351401 ENDOWRIST STAPLER 45 RELOAD ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention