BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 19055286 · Received April 5, 2024

    Report

    Report Number
    2955842-2024-13161
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 7, 2024
    Report Date
    March 13, 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
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. AN ADVANCED STAPLER LOG REVIEW SHOWED THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 3 TIMES AND FIRED 3 RELOADS (1 WHITE, FOLLOWED BY 2 GREEN). ON EACH INSTALL THE FIRST CLAMP WAS SUCCESSFUL. ON THE FIRST INSTALL, THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 2, THE FIRING WAS COMPLETED WITH 2-3 PAUSES FOR COMPRESSION. ON INSTALL 3, THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER-RELATED ERRORS IN THE SYSTEM LOGS. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE). THE REVIEW OF AN INTRAOPERATIVE IMAGE DID NOT PROVIDE FURTHER INSIGHT INTO THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC REVISION, THE SUREFORM 60 STAPLER MISFIRED. WHILE USING A GREEN SUREFORM 60 INSTRUMENT RELOAD ON THE GASTROJEJUNOSTOMY, THE INSTRUMENT CLAMPED AND PAUSED ONCE WHILE FIRING. WHILE SOME STAPLES APPEARED TO BE PROPERLY FORMED, SOME WERE NOT. PREVIOUSLY, THE INSTRUMENT FIRED ALL THE WAY THROUGH WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. DURING FOLLOW-UP WITH THE SURGEON, IT WAS STATED THAT THE TARGET TISSUE WAS THICKER DUE TO PREVIOUS SURGERIES. WHILE IT PAUSED FOR COMPRESSION, THE STAPLER FIRED WITH NO ERRORS. THERE WAS NO TISSUE TENSION, BUNCHING, OR PUSHING DURING THE FIRING. NO HARD OBJECTS WERE ENCOUNTERED, AND NO BUTTRESS MATERIAL WAS USED. AFTER THE FIRING WAS COMPLETED, THERE WAS UNEXPECTED TISSUE BLEEDING OF 50CC. HEMOSTASIS WAS ACHIEVED BY APPLYING PRESSURE AND OVERSEWING THE AREA. NO BLOOD PRODUCTS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447740 SUREFORM STAPLER 60 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48360G N/A

    Patients

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