BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 MM TROCAR

    MDR report key: 10605905 · Received September 29, 2020

    Report

    Report Number
    MW5096951
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 25, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY, THE 12MM DISPOSABLE TROCAR LOST INNER CLEAR PLASTIC RING DURING SURGERY. FIRST ASSISTANT AND SURGEON SAW IT LAYING INSIDE ABDOMEN DURING ROBOTIC PROCEDURE AND REMOVED THE PLASTIC CLEAR RING FROM ABDOMINAL CAVITY. (ITEM IS NOT RADIOPAQUE AND NOT NORMALLY VISUALIZED ON A TROCAR TO BE ABLE TO CONFIRM IT IS INTACT.) FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065755 12 MM TROCAR TROCAR ENDOSCOPE AND ACCESSORIES GCJ APPLIED MEDICAL RESOURCES CORP. 103954

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention