BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 23476316 · Received November 5, 2025

    Report

    Report Number
    23476316
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 13, 2025
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS, INC.
    Product Code
    NLM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    TROCAR CAP AND ENTIRE TOP PIECE OF TROCAR FELL APART WHILE PULLING GALLBLADDER OUT OF ABDOMEN. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED, N/A (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465082 N/A LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED NLM STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A 16652029

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male