BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    EUROMI REUSABLE CANNULA

    MDR report key: 17207114 · Received June 27, 2023

    Report

    Report Number
    3007697975-2018-00010
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    October 10, 2018
    Report Date
    June 27, 2023
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    PMA / PMN Number
    878.4800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CANNULAS HAVE NO LINEARITY OR CORROSION DEFECTS. THEY WERE USED ONLY ONCE IN A DEMONSTRATION. THE BATCH OF TUBING USED TO MAKE THE CANNULA IS COMPLIANT. A FOLD OF THIS TYPE AT THE CANNULA OCCURS: AFTER AN EXCESSIVE LOAD ON THE CANNULA (STRESS AMPLITUDE), OR IF THE CANNULA TUBE IS TOO THIN, OR IF THE TENSILE STRENGTH RM IS TOO LOW (< 460 MPA), OR IF THE DESIGN OF THE CANNULA IS NOT SUITABLE: THE SURFACE OF THE HOLES IS TOO LARGE, THUS CREATING A FRAGILITY OF THE CANNULA. THE OGIVE (TIP) IS CRUSHED AT THE HOLES, AS WELL AS THE TUBE. DESIGN REVIEW TO REINFORCE THE MECHANICAL RESISTANCE OF THE TUBE (DECREASE IN WIDTH AND HEIGHT). A BATCH RECALL IS NOT NECESSARY BECAUSE ALTHOUGH THE TUBE FOLDS AT THE HOLES WHEN INSERTED INTO THE PATIENT'S BODY, THE CANNULA DOES NOT BREAK. IN ADDITION, THE CANNULA IS CHECKED BEFORE EACH PROCEDURE (CF. INSTRUCTIONS). THE MERCEDES MODEL HAS BEEN AVAILABLE SINCE EUROMI OBTAINED THE CE MARKING FOR LIPOSUCTION CANNULAS (2009). CLAIMS AND CASES OF VIGILANCE ARE LIMITED WHEN CONSIDERING THE PERIOD 2011 - 2018 (PMS DATA AVAILABLE). THE DELAY IN MDR SUBMISSION IS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT. INITIALLY, REPORT WAS SENT IN VIA THE ESG PORTAL IN SEPTEMBER 2022 - DUE TO THE WRONG FORMAT BEING USED, IT IS RESENT.

    Description of Event or Problem · 0

    THE MERCEDES CANNULA FOLDED AT THE HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478069 EUROMI REUSABLE CANNULA CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA EUROMI SA MERCEDES TUNGSTEN 3*300 18AHAC309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other