BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 17102474 · Received June 11, 2023

    Report

    Report Number
    2955842-2023-16201
    Event Type
    Malfunction
    Date Received
    June 11, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DEVICE INVOLVED IN THIS COMPLAINT AND, THEREFORE, CANNOT PERFORM A DEVICE EVALUATION.

    Description of Event or Problem · 0

    ON 21-MAR-2023, INTUITIVE SURGICAL INC, (ISI) RECEIVED MW5115590 STATING: ROBOTIC GASTRIC BYPASS PROCEDURE. DURING PROCEDURE, ROBOTIC SUREFORM 60 STAPLER MALFUNCTIONED. THE SURGEON WAS UNABLE TO USE FULL RANGE OF MOTION WITH WRIST. A SECOND STAPLER WAS OPENED, THE SURGEON WAS STILL UNABLE TO USE FULL RANGE OF MOTION AND THE STAPLER WAS MOVING OUT OF SYNC WITH THE SURGEON'S MOVEMENTS WHICH IS A SAFETY CONCERN. A THIRD STAPLER WAS OPENED AND WORKED CORRECTLY. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875537 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 L13220725 10886874115647

    Patients

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