BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22759269 · Received August 8, 2025

    Report

    Report Number
    2955842-2025-33610
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117122
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE WHITE SUREFORM 45 RELOAD ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. THE RELOAD WAS RETURNED USED AND FIRED. IT WAS NOT RETURNED WITH AN INSTRUMENT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE CARTRIDGE, KNIFE, PUSHERS, OR COVER. THE COVER WAS REMOVED, AND THE RELOAD WAS INSPECTED. THERE WAS NO DAMAGE TO THE RELOAD OR ITS COMPONENTS. NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SUREFORM 45 STAPLER ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT. THE INSTRUMENT CLAMPED, FIRED, AND UNCLAMPED SUCCESSFULLY. NO PRODUCT ISSUE WAS FOUND. BASED ON THE INVESTIGATION RESULTS, CUSTOMER REPORTED ISSUES MAY BE DUE TO OTHER FACTORS UNRELATED TO THE PRODUCT.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. STAPLER LOGS SHOWED THE SUREFORM 45 STAPLER WAS INSTALLED ON THE SYSTEM 2 TIMES AND FIRED 2 WHITE RELOADS. ON EACH INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE STAPLE LINE OF A SUREFORM 45 WHITE RELOAD WAS INCOMPLETE, REQUIRING AN ADDITIONAL STAPLE LINE TO REPAIR THE DEFECT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361230 SUREFORM SUREFORM 45 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48345W-02 K10230928 10886874117122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES