BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 12643526 · Received October 15, 2021

    Report

    Report Number
    2955842-2021-11310
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 12, 2021
    Report Date
    September 22, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOWRIST STAPLER 45 INSTRUMENT INVOLVED WITH THIS EVENT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE STAPLER WAS TESTED IN-HOUSE, AND THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS REMOVED FROM THE IN-HOUSE SYSTEM AND RETESTED. THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED ON BOTH ATTEMPTS. NO MALFORMED STAPLES OR UNDEPLOYED PUSHERS WERE OBSERVED. UPON VISUAL INSPECTION, THE STAPLER DID NOT EXHIBIT ANY DAMAGE. A REVIEW OF INSTRUMENT LOGS SHOWED NO FAILURES. ROOT CAUSE IS ATTRIBUTED TO NON-DEVICE RELATED FACTORS.

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST AN ADVERSE EVENT AS PREVIOUSLY REPORTED DUE TO THE REPORT OF POSTOPERATIVE BLEEDING, WHICH COULD POTENTIALLY BE RELATED TO A PRODUCT PROBLEM. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1. B1 UPDATED FROM "ADVERSE EVENT" TO "ADVERSE EVENT AND PRODUCT PROBLEM".

    Description of Event or Problem · 0

    REFER FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION HAS NOT BEEN DETERMINED AS THE RELOAD WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. ISI HAS REQUESTED FOR RETURN OF THE STAPLER INSTRUMENT. HOWEVER, ISI HAS NOT RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE STAPLER INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS FOR THIS PRODUCT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ALTHOUGH THE TIP UP FENESTRATED GRASPER AND SMALL GRASPING RETRACTOR WERE NOT REUSED IN SUBSEQUENT PROCEDURES, A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THESE INSTRUMENTS. THE LOGS WERE REVIEWED BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE) AND THE FOLLOWING FINDINGS WERE OBTAINED: LOGS SHOW THAT STAPLER WITH PN 470298-14, LOT T10200917-0034 FIRED 5 RELOADS (ALL BLUE). ALL FIRINGS WERE COMPLETED PER THE LOGS. THERE WERE NO INCOMPLETE CLAMPS BY THIS INSTRUMENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO REPAIR A POST-OPERATIVE STAPLE LINE LEAK. THERE WAS NO ALLEGATION OF SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION DURING THE PROCEDURE. THE LOGS DID NOT INDICATE ANY ISSUES WITH THE STAPLING DURING THE PRIMARY PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED FROM THE SURGEON REGARDING THE HEALTH OF THE TISSUE THAT WAS STAPLED, WHETHER THERE WAS ANY PRE-EXISTING MEDICAL ILLNESS THAT CONTRIBUTED TO THE STAPLE LINE LEAK, AND WHICH PART OF THE INTESTINES LEAKED. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SALES REPRESENTATIVE (CSR) THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE WITH BOWEL RESECTION AND ANASTOMOSIS AND WAS DISCOVERED TO HAVE A STAPLE LINE LEAK POST-OPERATIVELY. THE PATIENT UNDERWENT A SECOND PROCEDURE TO FIX THE LEAK AND IS CURRENTLY RECOVERING WELL. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT HAD BOWEL TISSUE WHICH WAS CAUGHT IN THE HERNIA SAC AND UNDERWENT A RIGHT INGUINAL HERNIA REPAIR WITH BOWEL RESECTION AND ANASTOMOSIS. A SIDE-TO-SIDE ANASTOMOSIS WAS PERFORMED WITH THE ENDOWRIST STAPLER 45 FOR THE PROCEDURE. THE PATIENT WAS STILL ADMITTED TO THE HOSPITAL AND WAS FOUND TO HAVE A STAPLE LINE LEAK. ISI FOLLOWED UP WITH THE ROBOTIC COORDINATOR WHO CONFIRMED THAT THE BLUE RELOAD THAT WAS USED DURING THE PROCEDURE HAD BEEN DISCARDED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535738 ENDOWRIST STAPLER 45 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48645B-02 UNKNOWN

    Patients

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