BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 24965432 · Received April 23, 2026

    Report

    Report Number
    24965432
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 15, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    NWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING ROBOTIC LAPARSCOPIC PROCEDURE, A RAYTEC SPONGE WAS BEING REMOVED THROUGH THE TROCAR CANNULA WHEN IT SHREDDED INTO TWO PIECES. THE SPONGE WAS RETRIEVED AND THE SURGICAL FIELD WAS INSPECTED WITH NO REMNANTS OF SPONGE FOUND IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023568 CARDINAL HEALTH ENDOSCOPE INTRODUCER KIT NWU CARDINAL HEALTH 200, LLC SBAHDRSAGA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other