BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18501827 · Received January 12, 2024

    Report

    Report Number
    2955842-2024-10196
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: REFER TO THE UPDATED AWARENESS DATE IN FIELDS B4 AND G3. ADDITIONAL INFORMATION: REFER TO ADDITIONAL INFORMATION IN SECTION A, SECTION B, AND H10. DURING FOLLOW UP WITH THE SURGEON, IT WAS STATED THE BLEEDING SOURCE WAS LUNG TISSUE, THERE WAS 5-10 CC OF BLOOD LOSS, NO BUTTRESS MATERIAL WAS USED & IRRIGATION AND MONITORING WERE THE ONLY MEDICAL INTERVENTIONS PERFORMED DUE TO THIS EVENT. A REPAIR WAS NOT NEEDED, AS THERE WERE NO "GROSS AIR LEAKS." THERE WERE NO ISSUES FIRING THE STAPLER, NO CHANGE IN THE WAY THE SURGEON USES THE STAPLER, NOR WAS THERE ANYTHING OUT OF THE ORDINARY NOTED WITH THE STAPLER BEFORE OR DURING USE. THE ISSUE WAS RESOLVED WITH A BACK-UP STAPLER AND THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED.

    Additional Manufacturer Narrative · 0

    THE SUREFORM 45 STAPLER INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT "PORTION OF STAPLE LOAD DID NOT FIRE CAUSING BLEEDING ALONG THE STAPLE LINE." VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. THE STAPLER WAS TESTED IN-HOUSE, AND THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT ATTACHED TO AND REMOVED FROM THE ARM WITHOUT ANY ISSUES ON 3 ATTEMPTS. SYSTEM LOGS WERE UNABLE TO VERIFY ANY CLAMPING/UNCLAMPING FAILURES. THE INSTRUMENT WAS FULLY FUNCTIONAL AND THERE WAS NO PROBLEM DETECTED. IMAGES OF THE SUREFORM 45 STAPLER WERE PROVIDED BY THE CUSTOMER WITHOUT SIGNS INDICATIVE OF DAMAGE OR OTHER PRODUCT ISSUE, WHICH WAS CONFIRMED BY THE FAILURE ANALYSIS FINDINGS. THE STAPLER RELOAD HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. ADVANCED STAPLER LOGS SHOW THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 3 TIMES AND FIRED 3 GREEN RELOADS. ON INSTALLS 1 AND 3, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETE WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, THE FIRST CLAMP WAS ABORTED BY THE USER. THE NEXT CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE INVESTIGATION REVEALED NO RELATED SYSTEM ERROR OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    CORRECTION FOR SECTION B4 THIS IS A CORRECTION TO SUPPLEMENTAL #1 TO CORRECT THE US REPORTABILITY AWARE DATE AS THERE WAS A DATA ENTRY ERROR OF THE DATE. CORRECTED THE US REPORTABILITY AWARE DATE FROM 12/12/2024 TO 12/12/2023.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY WEDGE RESECTION, A PORTION OF THE STAPLE LOAD DID NOT FIRE WHICH CAUSED BLEEDING ALONG THE STAPLE LINE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER, HOWEVER, NO FURTHER DETAILS WERE PROVIDED AS THE REPORTER COULD NOT CONFIRM ANY ADDITIONAL INFORMATION. IT WAS INDICATED THAT THE SITE INTENDS TO RETURN THE ASSOCIATED STAPLER RELOAD. IMAGES OF THE SUREFORM 45 STAPLER PRODUCT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827486 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.