BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GRASPING FORCEPS FG-804L

    MDR report key: 16827532 · Received April 27, 2023

    Report

    Report Number
    2429304-2023-00083
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 27, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170435874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE USE GRASPING FORCEPS FG-804L DID NOT OPEN WHILE IT WAS GRASPING THE GASTROSTOMY-JEJUNOSTOMY (GJ) TUBE IN THE MIDDLE OF A THERAPEUTIC PROCEDURE TO REPLACE A GJ TUBE. OTHER THAN CUTTING THE FORCEPS, PULLING IT OUT, AND CHECKING FOR ANY FOREIGN BODIES, NO OTHER INTERVENTION WAS DONE OUTSIDE THE PLANNED CASE. THE PROCEDURE WAS PROLONGED BY 30 MINUTES, TWICE AS LONG AS ANTICIPATED, WITH THE PATIENT UNDER ANESTHESIA. HOWEVER, THERE WERE NO OTHER COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430150 SINGLE USE GRASPING FORCEPS FG-804L DISPOSABLE GRASPING FORCEPS EOQ AOMORI OLYMPUS CO., LTD. FG-804L 1XK 04953170435874

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Unknown Required Intervention