BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII FIOS

    MDR report key: 10837654 · Received November 12, 2020

    Report

    Report Number
    MW5097860
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 11, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PERFORMING A LAPAROSCOPIC HYSTERECTOMY, THE TIP OF APPLIED MEDICAL KII FIOS FIRST ENTRY CFF33 TROCAR BROKE INTO 3 PIECES. RESIDUAL WAS IN PATIENT'S ABDOMEN. ALL PARTICLES RETRIEVED FROM PATIENT BEFORE SURGERY ENDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298897 KII FIOS LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. CFF33 1384378

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention