BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18450425 · Received January 5, 2024

    Report

    Report Number
    2955842-2024-10028
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    October 26, 2023
    Report Date
    December 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    ISIFA2022-02-C
    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

    DUE TO A LACK OF SITE INFORMATION, POSITIVE IDENTIFICATION OF THE PROCEDURE/INSTRUMENTS IS UNABLE TO BE PERFORMED. THEREFORE, FURTHER INVESTIGATION OF SYSTEM LOGS IS ALSO UNABLE TO BE PERFORMED. .

    Description of Event or Problem · 0

    ON 12/08/2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5148325, MW5148326, MW5148327 STATING: DURING ROBOTIC THORACIC SURGICAL PROCEDURE, ROBOTIC STAPLING DEVICE DID NOT FIRE COMPLETELY. OUTERMOST ROW OF STAPLES WAS STILL IN THE STAPLE LOAD AFTER STAPLER FIRED RESULTING IN SMALL AMOUNT OF BLEEDING AT STAPLE LINE. NO ERROR MESSAGE GENERATED BY DA VINCI SYSTEM WHEN STAPLER FIRED. NEW STAPLE LOAD OPENED AND INSERTED INTO SAME STAPLE GUN. WHEN SURGEON ATTEMPTED TO USE STAPLER, SYSTEM RESPONDED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS OF THE STAPLER. SURGEON REPOSITIONED STAPLER. SAME ERROR MESSAGE RECEIVED. STAPLER REMOVED FROM SERVICE. NEW STAPLER WITH NEW LOAD OPENED AND USED WITHOUT INCIDENT. EVENT REPORTED TO INTUITIVE REP. ON 12/15/2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5148317 STATING: DURING ROBOTIC THORACIC SURGICAL PROCEDURE, ROBOTIC STAPLING DEVICE DID NOT FIRE COMPLETELY. OUTERMOST ROW OF STAPLES WAS STILL IN THE STAPLE LOAD AFTER STAPLER FIRED RESULTING IN SMALL AMOUNT OF BLEEDING AT STAPLE LINE. NO ERROR MESSAGES GENERATED BY DA VINCI SYSTEM WHEN STAPLER FIRED. NEW STAPLE LOAD OPENED AND INSERTED INTO SAME STAPLE GUN. WHEN SURGEON ATTEMPTED TO USE STAPLER, SYSTEM RESPONDED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS OF THE STAPLER. SURGEON REPOSITIONED STAPLER. SAME ERROR MESSAGE RECEIVED. STAPLER REMOVED FROM SERVICE. NEW STAPLER WITH NEW LOAD OPENED AND USED WITHOUT INCIDENT. EVENT REPORTED TO INTUITIVE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588201 SUREFORM SUREFORM 45 RELOAD BLACK GDW INTUITIVE SURGICAL, INC 48345T-02 L11230330

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES