BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20914659 · Received December 12, 2024

    Report

    Report Number
    2955842-2024-23102
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE BLUE SUREFORM 60 RELOAD OR SUREFORM 60 STAPLER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE BLUE SUREFORM 60 RELOAD ASSOCIATED WITH THE EVENT HAS NOT BEEN RETURNED. THE SUREFORM 60 STAPLER INSTRUMENT WAS RECEIVED FOR FAILURE ANALYSIS. THE REPORTED ISSUE WITH THE INSTRUMENT COULD NOT BE REPLICATED NOR CONFIRMED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE STAPLER WAS TESTED IN-HOUSE, AND THE INSTRUMENT INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. THE INSTRUMENT FIRED SUCCESSFULLY TWICE USING TWO BLUE 60 RELOADS. A REVIEW OF THE STAPLER LOGS SHOWED THE SUREFORM 60 STAPLER CLAMPED SUCCESSFULLY AND FIRED WITH NO PAUSES FOR COMPRESSION. THERE WERE NO STAPLER RELATED FAILURES IN THE LOGS. THERE WAS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION, LOW ANTERIOR RESECTION, AND APPENDECTOMY PROCEDURE, THE SUREFORM 60 STAPLER DID NOT COMPRESS WELL AT THE END OF THE STAPLE LINE WHERE A BLUE SUREFORM 60 RELOAD WAS FIRED AND A FEW STAPLES WERE SHED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING RESECTION OF BOWEL TISSUE. THE INCIDENT INVOLVED STAPLES FALLING OFF INSIDE THE PATIENT. THE STAPLES WERE MANUALLY RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE STAPLES. THE INITIAL REPORTER WAS UNABLE TO CONFIRM IF ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING STAPLES. THE INITIAL REPORTER WAS UNABLE TO CONFIRM WHAT STAPLER FIRE WAS INVOLVED AND IF THERE WAS ANY TISSUE CALCIFICATION OR TENSION OR BUNCHING, IF THE EVENT INVOLVED A FAILURE TO/PARTIAL FIRE OR TISSUE PUSHOUT OR DEPLOYMENT OF STAPLES UNEXPECTEDLY. THE RELOAD DID NOT HAVE AN EXPOSED BLADE AND WAS NOT STUCK TO TISSUE. THE INITIAL REPORTER COULD NOT CONFIRM IF THERE WERE MALFORMED STAPLES OR IF ANY STAPLES WERE MISSING FROM THE STAPLE LINE OR IF THERE WERE HOLES/GAPS OBSERVED WITHIN THE STAPLE LINE. NO ERRORS/MESSAGES WERE GENERATED WHEN THE STAPLING ISSUE OCCURRED. 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 REPORTER COULD NOT CONFIRM IF THE SURGEON FIRED OVER AN EXISTING STAPLE LINE OR EXPERIENCED ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD OR IF ANY BLEEDING WAS OBSERVED ON THE STAPLE LINE. THERE WAS NO UNPLANNED TISSUE REMOVAL DUE TO THE STAPLER FIRING FAILURE. THE INSTRUMENT WAS SENT BACK FOR EVALUATION AND THE STAPLER RELOAD IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203073 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B N/A

    Patients

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