BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 21069252 · Received January 3, 2025

    Report

    Report Number
    2955842-2025-00049
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 7, 2024
    Report Date
    December 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874121914
    PMA / PMN Number
    K211997
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM 30 BLUE RELOAD INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 30 STAPLER RELOAD (BLUE) WAS ANALYZED AND FOUND TO HAVE THE PUSHER NOT IN THE EXPECTED POSITION WITHIN CARTRIDGE POCKET. THE PUSHERS ROTATED FORWARD, CAUSING THE STAPLES TO NO LONGER BE SEATED IN THE PUSHER POCKETS. THERE WAS NO DAMAGE FOUND TO THE RELOAD. THE COMPLAINT REGARDING THE BLUE RELOAD HAS STAPLES COMING OUT WHEN INSERTED INTO THE FIELD WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF RELOAD DAMAGE IS ATTRIBUTED A DISLODGED RELOAD PUSHER DUE TO THE COMPONENT¿S SUSCEPTIBILITY TO DAMAGE.

    Additional Manufacturer Narrative · 0

    THE SUREFORM STAPLER RELOAD (BLUE) HAS BEEN EVALUATED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE INITIAL FINDINGS WERE PARTIALLY CONFIRMED. THE RELOAD WAS RETURNED FOR PROTRUDING STAPLES AT THE DISTAL END. THE RELOAD WAS RETURNED WITH STAPLES MISSING FROM THE RIGHT SIDE MOST PROXIMAL SIX PUSHERS. MINOR CARTRIDGE DAMAGE WAS OBSERVED ON THE PROXIMAL END, NEAR THE FIRST PUSHER. PREVIOUS INVESTIGATIONS HAVE FOUND THAT MISALIGNMENT OF THE RELOAD WITHIN THE STAPLER CHANNEL MAY RESULT IN THE KNIFE TRACK PUSHING AGAINST THE FIRST FEW ROWS OF STAPLES. THE CARTRIDGE DAMAGE TO THE PROXIMAL END IS FURTHER EVIDENCE OF MISALIGNMENT DURING INSTALLATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE SUREFORM 30 BLUE RELOAD HAD STAPLES COMING OUT WHEN INSERTED INTO THE FIELD. THE CUSTOMER ADVISED THAT THE RELOAD WAS NEW AND THEY WERE CONFIDENT THEY WEREN'T UTILIZING ONE THAT HAD BEEN USED ALREADY. AS A RESULT, THE CUSTOMER OPENED A NEW RELOAD TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RELOAD WAS NOT FIRED PRIOR TO THE IDENTIFIED ISSUE AND THE EVENT DID NOT RESULT IN LOOSE STAPLES FALLING INTO THE PATIENT ANATOMY. THE INCIDENT DID NOT RESULT IN MALFORMED OR UNFORMED STAPLES, THE RELOAD HAVING AN EXPOSED BLADE, STAPLES MISSING FROM THE STAPLE LINE, HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE, OR THE RELOAD BEING STUCK TO TISSUE. THERE WAS NO BLEEDING OBSERVED ON THE STAPLE LINE DUE TO THE ISSUE. ADDITIONALLY, THERE WERE NO ERRORS/MESSAGES GENERATED AS THE DEFECT WAS NOTED AS SOON AS THE RELOAD WAS INSERTED. THE PART NUMBER AND LOT NUMBER FOR THE STAPLER INSTRUMENT WAS NOT NOTED AND THE SAME STAPLER INSTRUMENT WAS UTILIZED FOR THE REPLACEMENT RELOAD WHICH WORKED FINE. PHOTOGRAPHIC IMAGES OR A VIDEO RECORDING OF THE PROCEDURE IS NOT AVAILABLE FOR ISI 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
    640186 SUREFORM 8MM STAPLER NAY INTUITIVE SURGICAL, INC 48230B-05 U80231109 10886874121914

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES