BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 21405224 · Received February 18, 2025

    Report

    Report Number
    2955842-2025-01620
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    October 4, 2024
    Report Date
    January 20, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113827
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AS OF THE DATE OF THIS REPORT, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE WHITE SUREFORM 60 RELOAD INVOLVED WITH THE REPORTED EVENT. AN INSTRUMENT LOG REVIEW COULD NOT BE CONDUCTED DUE TO INSUFFICIENT INFORMATION PROVIDED. THE BATCH SEQUENCE # OF THE ASSOCIATED WHITE SUREFORM 60 RELOAD WAS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE WHITE SURE FORM 60 RELOAD FOR FAILURE ANALYSIS EVALUATION. THE EVENT INVESTIGATION IS IN PROGRESS.

    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 SUBTOTAL GASTRECTOMY PROCEDURE, THE STAPLES FROM A WHITE SUREFORM 60 RELOAD DID NOT FULLY DEPLOY AND THE STAPLING SEQUENCE WAS NOT FULLY COMPLETED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT OCCURRED DURING THE 2ND STAPLER FIRE ON STOMACH TISSUE AS PART OF A SLEEVE GASTRECTOMY. THE STAPLER INSTRUMENT HAD INITIALLY WORKED FOR THE FIRST FIRING. THE STOMACH TISSUE WAS NOT CALCIFIED OR EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE, AND THERE WAS NO TISSUE TENSION OR TISSUE BUNCHING. THE STAPLER INSTRUMENT CLAMPED DOWN NORMALLY AND WAS READY TO FIRE. DURING THE FIRING, THE STAPLER INSTRUMENT PARTIALLY FIRED AND HAD STOPPED WITH A TISSUE TOO THICK TO CONTINUE MESSAGE. THE STAPLING ISSUE RESULTED WITH A FEW LOOSE AND UNFORMED STAPLES WHICH WERE REMOVED BEYOND THE STOP POINT. THE STAPLE LINE WAS OTHERWISE INTACT. THE STAPLER RELOAD HAD AN EXPOSED BLADE. THERE WERE NO STAPLES MISSING FROM THE STAPLE LINE. THERE WERE ALSO NO HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE. THE SURGEON ENCOUNTERED A NUMBER OF STAPLING ERROR MESSAGES DURING THE EVENT. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. BUTTRESS MATERIAL WAS NOT USED. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. NO BLEEDING WAS OBSERVED ON THE STAPLE LINE DUE TO THE STAPLER ISSUE. THERE WAS NO UNPLANNED TISSUE REMOVAL DUE TO THE STAPLER FIRING FAILURE. THE STAPLING ISSUE DID NOT RESULT IN HOLES/GAPS (UNAPPROXIMATED TISSUE) IN THE STAPLE LINE. THE SURGEON WAS ABLE TO CONTINUE THE PROCEDURE USING OTHER WHITE SUREFORM 60 RELOADS. THERE ARE VIDEO FILES AVAILABLE FOR ISI TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60171 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-10 K11240801 10886874113827

    Patients

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