BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20969400 · Received December 18, 2024

    Report

    Report Number
    2955842-2024-23202
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 21, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K211997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN ADVANCED STAPLER LOG INVESTIGATION BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE) REVEALED THE FOLLOWING: THE LOGS SHOW A SUREFORM 30 STAPLER INSTRUMENT (PART #4808530-12, LOT #U80231017-0035) WAS INSTALLED ON THE SYSTEM 9 TIMES AND FIRED 7 RELOADS (4 BLUE, FOLLOWED BY 3 WHITE). ON INSTALL 1, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR AND THE USER MANUALLY SELECTED THE BLUE SUREFORM 30 RELOAD. NO CLAMPING OR FIRING WAS ATTEMPTED. NO CLAMPING OR FIRING WAS ATTEMPTED ON INSTALL 2. ON INSTALLS 3-9, BARRING ONE ABORTED CLAMP ON INSTALL 4, ALL CLAMP ATTEMPTS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POSTOPERATIVE AIR LEAK. DURING THE INITIAL PROCEDURE, THE SURGEON STAPLED THE FISSURE WITH BLUE SUREFORM 30 RELOADS, USING A SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT. WHITE SUREFORM 30 RELOADS WERE ALSO USED DURING CASE. ALL STAPLE LINES WERE CREATED CORRECTLY WITHOUT ANY STAPLING ERROR MESSAGES. THE STAPLE LINES WERE COMPLETE AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS. ON POST-OPERATIVE DAY ONE, AN AIR LEAK WAS IDENTIFIED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION (IF ANY) WAS REQUIRED DUE TO THE COMPLICATION. THE PATIENT IS STILL HOSPITALIZED BUT IN STABLE CONDITION, WITH AN EXPECTED RECOVERY. AN ETHICON 30 STAPLER AND GREEN RELOAD WERE USED TO STAPLE THE BRONCHUS. ACCORDING TO THE INITIAL REPORTER, THERE WERE NO ISSUES WITH THE ETHICON 30 STAPLER DEVICE. THE ORIGIN OF THE LEAK IS UNABLE TO BE IDENTIFIED. THE SURGEON RELATED THE EVENT TO HAVING AIR LEAKS IN PROCEDURES IN THE PAST WITH LAPAROSCOPIC CASES AND DID NOT IDENTIFY THAT THE DA VINCI SYSTEM WAS DIRECTLY THE CAUSE OF THE PATIENT'S COMPLICATION. IT WAS NOTED THAT THE SUREFORM 30 CURVED-TIP STAPLER INSTRUMENT IS THE ONLY NEW PRODUCT AND TECHNIQUE USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283623 SUREFORM 8MM STAPLER GDW INTUITIVE SURGICAL, INC 48230 N/A

    Patients

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