BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIED MEDICAL KII OPTICAL ACCESS SYSTEM TROCAR

    MDR report key: 18816450 · Received February 28, 2024

    Report

    Report Number
    MW5152221
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 27, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING LAPAROSCOPIC ROBOTIC PROCEDURE RUBBER INTERIOR OF 15MM TROCAR DETACHED INTO THE PATIENT'S CAVITY. THE OBJECT WAS REMOVED FROM THE PATIENT, THE TROCAR WAS REMOVED, AND BOTH WERE ASSESSED. IT WAS CONFIRMED THAT ALL PARTS OF THE DEFECTIVE TROCAR WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534818 APPLIED MEDICAL KII OPTICAL ACCESS SYSTEM TROCAR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. 1506569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention