BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 23639699 · Received November 24, 2025

    Report

    Report Number
    2955842-2025-45740
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT WITH BLUE RELOAD WAS STUCK ON THE LUNG TISSUE. THE CUSTOMER WAS ABLE TO RELEASE IT FROM THE TISSUE AND STATED THEY WERE ABLE TO REMOVE IT, AND IT HAD ALREADY CUT AND STAPLED THE TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON COULD NOT FIND HOW TO RELEASE THE TISSUE. AFTER STAPLING AND CUTTING THE CUSTOMER PULLED THE STAPLER INSTRUMENT OFF THE LUNG TISSUE. THE TISSUE WAS ABLE TO BE RELEASED HOWEVER THE STAPLER INSTRUMENT JAWS WERE STUCK IN A SHUT POSITION. WHEN THE CUSTOMER FOUND HOW TO USE THE DIAL IT FAILED TO OPEN. THERE WAS NO PATIENT INJURY. THE INSTRUMENT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314671 SUREFORM SUREFORM 45 NAY INTUITIVE SURGICAL, INC 480445 N/A

    Patients

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