BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 23223764 · Received October 6, 2025

    Report

    Report Number
    2955842-2025-40424
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE STAPLER LOGS SHOWED THE SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM 6 TIMES AND FIRED 3 SUREFORM 60 RELOADS (2 GREEN, 1 BLUE). ON INSTALL 1, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1-2 PAUSES FOR COMPRESSION. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON THE NEXT 3 INSTALLS, THE STAPLER FAILED TO INITIALIZE WITH THE SYSTEM. PARAMETERS OF THE ERRORS INDICATE THAT HIGH DRIVETRAIN FRICTION WAS DETECTED IN EACH CASE. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. ADDITIONAL PATIENT INFORMATION: BMI OF 51 AND IS 1.63 M TALL. NOTE: THIS MEDWATCH REPORT (MDR) CAPTURES THE FIRST BLUE SUREFORM 60 RELOAD USED IN THIS PROCEDURE. REFER TO MDR WITH MANUFACTURER REPORT #2955842-2025-40429 FOR MDR SUBMISSION OF THE SECOND BLUE SUREFORM 60 RELOAD USED IN THIS PROCEDURE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H6, H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM (SF) 60 INSTRUMENT WAS ANALYZED, AND THE INITIALIZATION FAILURE WAS OBSERVED IN THE LOGS BUT NOT REPLICATED DURING IN-HOUSE TESTING. THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES TWO CONSECUTIVE TIMES WITH SF 60 BLACK RELOAD. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT: UPON INSPECTION, THE I-BEAM WAS MANUALLY DRIVEN OUT AND WAS FOUND WITH LODGED STAPLES IN THE I-BEAM INDICATOR WINDOW, LIKELY CAUSING THE HIGH DRIVETRAIN FRICTION FAILURES DURING INITIALIZATION ACCORDING TO LOGS. THE INSTRUMENT WAS FOUND TO HAVE A HIGH DRIVETRAIN FRICTION FAILURE BASED ON LOG REVIEW 3 TIMES. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES TWO CONSECUTIVE TIMES WITH SF 60 BLACK RELOAD ALTHOUGH WAS FOUND WITH LODGED STAPLE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, TISSUE WAS PUSHED AND NOT PROPERLY STAPLED OR CUT WHEN A BLUE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. IT IS UNCLEAR IF THE STAPLING ISSUE OCCURRED 1 OR 2 TIMES DURING THE CASE. THE STAPLES WERE NOTED TO BE "STUFFING" DURING THE CUTTING OF THE TISSUE RESULTING IN A GASTRIC PERFORATION. NO FRAGMENTS WERE NOTED TO HAVE FALLEN IN THE PATIENT, AND NO ADDITIONAL EXAMINATIONS WERE PERFORMED POST-OPERATIVELY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A 15-TO-30-MINUTE DELAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ABNORMALITIES WERE OBSERVED DURING THE INSTRUMENT INSPECTION PRIOR TO USE. THE INCIDENT OCCURRED DURING THE THIRD FIRING WITH A BLUE SUREFORM 60 RELOAD. THE GASTRIC GREATER CURVATURE AT THE LEVEL OF THE ¿CROW¿S FOOT¿ WAS BEING TRANSECTED AT THE TIME OF THE FIRING. NO TISSUE TENSION, FIBROSIS OR SIGNS OF FRAGILITY WERE OBSERVED. THE TISSUE WAS REPORTED TO BE PUSHED DURING THE FIRING PROCESS DURING TISSUE TRANSECTION. NO SYSTEM ERRORS WERE REPORTED. NO MALFORMED OR MISSING STAPLES, EXPOSED BLADES, OR GAPS WERE OBSERVED IN THE STAPLE LINE. THE GASTRIC PERFORATION WAS IMMEDIATELY VISIBLE; THEREFORE, SUTURING AND REINFORCEMENT OF THE STAPLE LINE USING A CONTINUOUS OVERLAY SUTURE, PLUS HEMOSTASIS AND PLACEMENT OF A DRAIN ALONG THE STAPLE LINE WERE PERFORMED. BLEEDING WITH AN ESTIMATED BLOOD LOSS VOLUME OF 150 CC WAS OBSERVED FROM THE GASTRIC TISSUE. A NEW SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED TO COMPLETE THE PROCEDURE. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A RESULT OF THIS REPORTED EVENT. NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS ARE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469863 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-10 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.