BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFORM

    MDR report key: 16215895 · Received January 20, 2023

    Report

    Report Number
    2955842-2023-10208
    Event Type
    Death
    Date Received
    January 20, 2023
    Date of Event
    January 3, 2022
    Report Date
    December 23, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON STATED THAT THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION WAS DUE TO THE CROSSING OF THE STAPLE LINES DURING THE PRIMARY PROCEDURE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE CANNOT BE CONFIRMED AS THE INSTRUMENT AND RELOADS WERE DISCARDED BY THE SITE AND WERE NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE STAPLER LOGS WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING FINDINGS WERE OBTAINED: LOGS SHOW THAT SUREFORM STAPLER WITH PART # 480460-09 WAS INSTALLED 11X AND FAILED TO ENGAGE ON THE 6TH ATTEMPT. LOGS SHOW ERROR 22020, WITH PARAMETERS OF THE ERROR INDICATING THE WRIST PITCH AXIS FAILED TO ENGAGE. THE OTHER 10 INSTALL ATTEMPTS SUCCESSFULLY ENGAGED WITH THE SYSTEM AND 8 RELOADS WERE FIRED (1 BLACK, FOLLOWED BY 7 GREEN). THERE WAS NO CLAMPING OR FIRING ATTEMPTED ON INSTALLS 3 AND 5. ON INSTALLS 4 AND 6, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR AND THE USER MANUALLY SELECTED THE GREEN RELOAD ON THE SURGEON`S TOUCHPAD. THERE WERE NO INCOMPLETE CLAMPS, INCOMPLETE UNCLAMPS, OR FIRING FAILURES FOR THIS INSTRUMENT. ALL FIRINGS WERE COMPLETED WITH NO PAUSES FOR COMPRESSION, EXCEPT FOR THE LAST FIRING, WHICH HAD 1 PAUSE FOR COMPRESSION. LOGS SHOW THE ENGAGEMENT FAILURE ERROR, BUT NO OTHER STAPLER RELATED ERRORS WERE OBSERVED. THE CASE WAS REVIEWED BY CLINICAL DEVELOPMENT ENGINEERING AND THE FOLLOWING INFORMATION WAS OBTAINED: ¿CROSS POINTS¿ MEANS IT SOUNDS LIKE THE SURGEON CROSSED OVER HIS 1ST STAPLE LINE WHILE PERFORMING HIS 2ND STAPLE FIRE. THE FOLLOWING WARNING IS AVAILABLE IN THE STAPLER INSTRUCTIONS FOR USE (IFU) : WARNING: STAPLING ACROSS ANOTHER STAPLER LINE MAY LEAD TO TISSUE DAMAGE OR DISRUPTION OF THE PREVIOUS STAPLE LINE. A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATE OF (B)(6) 2022 WAS PERFORMED BY A TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: MULTIPLE PROCEDURES WERE PERFORMED ON THIS SYSTEM AFTER THIS REPORTED EVENT WITH NO SERVICE REQUESTS BEING CREATED. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AS A RESULT OF THIS REVIEW, THE TSE DID NOT RECOMMEND A FIELD SERVICE ENGINEER (FSE) VISIT THE SITE TO PERFORM SYSTEM VERIFICATION TESTING. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: AN AORTO-ESOPHAGEAL FISTULA IS A DEVASTATING COMPLICATION FOLLOWING THIS TYPE OF SURGERY. THIS PARTICULAR COMPLICATION HAPPENED IN A VERY DELAYED FASHION, NEARLY 3 WEEKS AFTER SURGERY. THE CAUSE OF THESE TYPES OF POST-OPERATIVE COMPLICATIONS CAN BE AS A RESULT OF SINGULAR ISSUES OR MULTIFACTORIAL AND INCLUDE BUT ARE NOT LIMITED TO EVENTS THAT OCCUR OVER TIME SUCH AS ISCHEMIA, INFECTION, OR EVENTS THAT MAY BE MORE RELATED TO THE INITIAL SURGERY SUCH AS DIRECT INJURY TO THE ESOPHAGUS, AORTA OR BOTH AT THE TIME OF INITIAL SURGERY. NO MATTER THE CAUSE OR THE COMBINATION OF POSSIBLE CAUSES, THE BLEEDING CAN BE MASSIVE WITH RAPIDLY DEVASTATING CONSEQUENCES. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS AND THE DELAYED TIMELINE TO THIS PARTICULAR EVENT AND COMPLICATION, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF ANY ISI EQUIPMENT OR INSTRUMENTATION CONTRIBUTED TO THIS CATASTROPHIC EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED ESOPHAGECTOMY WITH INTRATHORACIC ANASTOMOSIS PROCEDURE, THE PATIENT PRESENTED WITH A STAPLE LINE LEAK ON THE 19TH POST-OPERATIVE DAY (POD). THE LEAK WAS DISCOVERED AT THE CROSS POINT OF THE 1ST AND 2ND STAPLE LINE. THE LEAK CAUSED AN AORTO-ESOPHAGEAL FISTULA WHICH RESULTED IN ACUTE BLEEDING TO THE GASTROINTESTINAL TRACT. A BALLOON TAMPONADE OF THE GASTRIC TUBE AND PLACEMENT OF A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS DONE FOR THE BLEEDING. THE PATIENT DIED OF MASSIVE BLEEDING BEFORE A RIGHT THORACOTOMY COULD BE PERFORMED. DURING THE PRIMARY PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR STAPLING ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED ESOPHAGECTOMY WITH INTRATHORACIC ANASTOMOSIS PROCEDURE, A LEAK WAS DISCOVERED ON THE 19TH POST-OPERATIVE DAY (POD) AT THE VERTICAL STAPLE LINE OF THE GASTRIC CONDUIT. THE LEAK WAS DISCOVERED AT THE CROSS POINT OF THE 1ST AND 2ND STAPLE LINE. THE LEAK CAUSED AN AORTO-ESOPHAGEAL FISTULA WHICH RESULTED IN ACUTE BLEEDING TO THE GASTROINTESTINAL TRACT (GIT). A BALLOON TAMPONADE OF THE GASTRIC TUBE AND PLACEMENT OF A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) WAS DONE TO TREAT THE BLEEDING. THE PATIENT DIED OF MASSIVE BLEEDING BEFORE A RIGHT THORACOTOMY COULD BE PERFORMED. DURING THE PRIMARY PROCEDURE, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR STAPLING ISSUES. THERE WERE NO ERROR MESSAGES, OBSTRUCTION IN THE JAWS OF THE STAPLER, BUTTRESS MATERIAL USED, NO CLAMPING ISSUES AND NO MALFORMED STAPLES PRODUCED. THE SURGICAL STAFF STATED THAT THEY WASH THE STAPLERS BETWEEN EACH STAPLER FIRES. THE TARGET TISSUE (GASTRIC TISSUE) DID NOT HAVE CALCIFICATIONS OR TISSUE TENSION AND WAS NOT EXPOSED TO CHEMOTHERAPY/RADIATION. THERE WAS NO TISSUE BUNCHING DURING STAPLING. THE STAPLER AND RELOADS HAD BEEN DISCARDED BEFORE THE CREATION OF THIS COMPLAINT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, NO FURTHER DETAILS WERE RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004846 SUREFORM STAPLER 60 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48360G N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES