BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED MEDICAL KII FIOS FIRST ENTRY 12X100 MM

    MDR report key: 11817414 · Received May 12, 2021

    Report

    Report Number
    MW5101326
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 11, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING TROCAR FOR PATIENT¿S PROCEDURE, IT WAS NOTED THAT THE TIP OF ONE OF THE TROCAR WAS BROKEN. TROCAR WAS REMOVED FROM THE PATIENT AND BROKEN BIT WAS RETRIEVED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706823 APPLIED MEDICAL KII FIOS FIRST ENTRY 12X100 MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. 1404310

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR