BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 24815079 · Received April 8, 2026

    Report

    Report Number
    2955842-2026-20777
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 8, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE SUREFORM 60 STAPLER INSTRUMENT OR ASSOCIATED SUREFORM 60 WHITE RELOAD TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE STAPLER LOG SHOWS THAT SUREFORM 60 STAPLER INSTRUMENT, (LOT NUMBER: K18250913-0153), WAS INSTALLED ON THE SYSTEM 8 TIMES AND FIRED 8 WHITE STAPLER RELOADS. ON INSTALL 1, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 6 PAUSES FOR COMPRESSION. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1-2 PAUSES FOR COMPRESSION. ON INSTALL 3, THE FIRST CLAMP WAS INCOMPLETE. THE NEXT CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2-3 PAUSES FOR COMPRESSION. ON INSTALLS 4 AND 5, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH 1-2 PAUSES FOR COMPRESSION. ON INSTALL 6, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 7, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 8, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE ANASTOMOSIS DUODENO-ILEAL BYPASS WITH SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING WHICH NECESSITATED EXTENSIVE POSTOPERATIVE CARE AND A PROLONGED HOSPITALIZATION. A SUREFORM 60 STAPLER INSTRUMENT EQUIPPED WITH A SUREFORM 60 WHITE RELOAD WERE USED DURING THE REPORTED PROCEDURE. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE COMPLICATION OCCURRED, THE ESTIMATED BLOOD LOSS ASSOCIATED WITH THE BLEEDING, AND WHAT SURGICAL INTERVENTION WAS RENDERED TO CONTROL THE BLEEDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877057 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.