BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII FIOS FIRST ENTRY 12 X 100MM

    MDR report key: 16974534 · Received May 19, 2023

    Report

    Report Number
    MW5117737
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 17, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING RIB FX (FRACTURE) FIXATION FOR MULTIPLE FRACTURES OF RIBS; USING THORACOSCOPY APPROACH, A SMALL PIECE OF THE DISTAL END OF THE 12 MM PLASTIC PORT (TROCAR) WAS FOUND DISLODGED FROM THE PORT ITSELF. THIS WAS NOT ASSOCIATED WITH ANY SPECIFIC MANEUVERS. A SMALL PIECE WAS FOUND BUT NOT ALL. RISK OF OPEN PROCEDURE WAS RULED OUT TO FIND THE OTHER PIECE. X-RAY DID NOT FIND ANYTHING MORE BUT NOT ALL OF THE BROKEN TROCAR WAS ACCOUNTED FOR. PATIENT WAS MADE AWARE DURING HIS ENCOUNTER. BROKEN TROCAR HAS BEEN SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666646 KII FIOS FIRST ENTRY 12 X 100MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. 1477673

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention