BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP

    MDR report key: 19664649 · Received July 3, 2024

    Report

    Report Number
    19664649
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 4, 2024
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COVIDIEN - STEP DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE 12MM SHORT REF: S100712 LOT: P2F0399 - HAD A PLASTIC PIECE OF THE DIAPHRAGM BREAK OFF INTO THE PATIENT'S ABDOMEN ON INSERTION OF THE CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785505 STEP LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN S100712 P2F0399

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DA Male