BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 21910802 · Received April 25, 2025

    Report

    Report Number
    2955842-2025-16463
    Event Type
    Injury
    Date Received
    April 25, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 28, 2025
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A PRODUCT FOR FAILURE ANALYSIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SINGLE ANASTOMOSIS DUODENAL-ILEAL SWITCH (SADI) AND SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT WAS RE-ADMITTED AFTER DISCHARGE WITH ABDOMINAL PAIN. A CT-SCAN CONFIRMED A HEMATOMA NEXT TO THE STAPLE LINE WHERE A SUREFORM 60 STAPLER INSTRUMENT AND SUREFORM 60 RELOAD(S) WERE USED. AT THIS TIME THERE IS INSUFFICIENT INFORMATION TO INDICATE THE SEVERITY OF THE INJURY AND THE CAUSE OF THE REPORTED COMPLICATION IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825363 SUREFORM STAPLER 60 RELOAD GDW INTUITIVE SURGICAL, INC 48360 N/A

    Patients

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