BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18419631 · Received December 29, 2023

    Report

    Report Number
    2955842-2023-21804
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    September 19, 2023
    Report Date
    November 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. ADVANCED STAPLER LOGS SHOW THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 6 TIMES AND FIRED 6 WHITE RELOADS. ON INSTALLS 1 AND 3, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2-3 PAUSES FOR COMPRESSION. ON INSTALLS 4-6, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. AFTER INSTALL 6, THE STAPLER WAS REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM LOGS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE UNIVERSAL SURGICAL MANIPULATOR (USM) THE SURGEON TYPICALLY USES THE STAPLER WITH WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) TO RULE OUT CAUSATION. THE USM PASSED AN IN-HOUSE STAPLER TEST AND THERE WAS NO TROUBLE RELATED TO THE REPORTED EVENT FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED ROUX-EN-Y, THE PATIENT EXPERIENCED INTRALUMINAL BLEEDING. THERE WERE NO INTRAOPERATIVE ISSUES OR RECENT SURGICAL TECHNIQUE CHANGES. ADDITIONALLY, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED DURING THE PROCEDURE WITH NORMAL FINDINGS. DURING FOLLOW UP WITH THE PHYSICIAN'S ASSISTANT (PA), THROUGH THE CLINICAL SALES REPRESENTATIVE (CSR), IT WAS STATED THAT THE BLEEDING SOURCE WAS THE JEJUNO-JEJUNAL ANASTOMOSIS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285478 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W N/A

    Patients

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