BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA

    MDR report key: 16751077 · Received April 17, 2023

    Report

    Report Number
    3007697975-2023-00004
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 2, 2018
    Report Date
    September 16, 2022
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    PMA / PMN Number
    878.4800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BREAKAGE OF THE CANNULA OCCURRED AT THE BASE. A DEFORMATION IS VISIBLE ON THE TUBE, NEAR THE BASE. THIS DEFORMATION PROBABLY CHANGED THE PROPERTIES OF THE MATERIAL. THIS CAUSES THE FORMATION OF CRACKS AND RUPTURE OF THE CANNULA. THIS DISTORTION CAN APPEAR FOLLOWING: - A FOLD OF THE CANNULA: TO ACCESS DIFFICULT AREAS OR TO AVOID USING SEVERAL DIFFERENT CANNULAS, THE SURGEON WAS ABLE TO BEND THE CANNULA AT THE BASE; - A SHOCK IN THE AREA WHERE THE BREAK OCCURRED. NO FINDING ALLOWS US TO SELECT ONE OF THE TWO HYPOTHESES. EUROMI CONTROLS EACH OF ITS CANNULAS (UNITARY CONTROL) BEFORE RELEASING ITS LOT. THIS CANNULA WAS CHECKED (EVIDENCE IN THE CANNULA LOT RECORD) AND WAS COMPLIANT PRIOR TO RELEASE. WE BELIEVE THAT THE DEFORMATION HAS OCCURRED AT THE CUSTOMER. A PRECISION ALREADY APPEARS IN THE INSTRUCTIONS THAT ARE PROVIDED TO THE CLIENT, STATING THAT THE CANNULA SHOULD NOT BE BENT AND THAT AN INSPECTION OF THE CANNULA IN THE AREAS CONCENTRATING THE MOST STRESS MUST TAKE PLACE BEFORE EACH USE (WARHEAD, BASE, HOLES). DEFORMATION OF THE CANNULA RESULTED IN THE FORMATION OF CRACKS AND RUPTURE OF THE CANNULA. THE DELAY IN MDR SUBMISSION IS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT.

    Description of Event or Problem · 0

    DURING A LIPOSUCTION PROCEDURE, A CANNULA BROKE CLEAN IN THE PATIENT'S BODY. THE CANNULA BROKE AT THE BASE AND THE SURGEON WAS ABLE TO REMOVE IT IMMEDIATELY. NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319769 CANNULA CANULE 3G INOX 3*350 GEA EUROMI SA ASPIRATION CANULA 3G 16EEHI305

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other