BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 18703828 · Received February 14, 2024

    Report

    Report Number
    18703828
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 2, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    FDE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN PREPARING FOR AN OR CASE, UPON COUNTING SPONGES IT WAS NOTED THAT THERE WERE NINE (9) RAY-TEC X-RAYABLE SPONGES IN THE PACK INSTEAD OF 10. SPONGES PASSED OFF FIELD, NEW PACK OF SPONGES OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388819 ACS LAPAROSCOPY KIT FDE AMERICAN CONTRACT SYSTEMS HOLC64F 708231

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown