BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM 60

    MDR report key: 15418641 · Received September 13, 2022

    Report

    Report Number
    MW5112011
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    September 8, 2022
    Report Date
    September 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SUREFORM 60 STAPLER NOT WORKING PROPERLY. "ENGAGEMENT ERROR." REF: 480460, LOT: L10220803; NO PATIENT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621182 SUREFORM 60 STAPLE, IMPLANTABLE GDW INTUITIVE SURGICAL, INC. 480460 L10220803

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose