BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EUROMI REUSABLE CANNULA

    MDR report key: 17189450 · Received June 23, 2023

    Report

    Report Number
    3007697975-2020-00002
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    February 11, 2020
    Report Date
    June 13, 2023
    Manufacturer
    EUROMI SA
    Product Code
    GEA
    PMA / PMN Number
    878.4800
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS TYPE OF CANNULA HAS NOT BEEN MANUFACTURED SINCE 2015. THE LOT NUMBER IS NO LONGER LEGIBLE, INDICATING ABNORMAL USE OF THE DEVICE (SIGNIFICANTLY MORE THAT THE RECOMMENDED 200 USE / 2 YEARS). THE CANNULA SHOULD NOT BE USED FOR MORE THAN 2 YEARS OR 200 USES. UPON FURTHER REQUEST, IT WAS DISCOVERED THAT THE SURGEON HAS HAD THIS CANNULA FOR OVER 14 YEARS. AS A RESULT, IT IS CONCLUDED THAT THE SURGEON DID NOT FOLLOW THE INSTRUCTIONS FOR USE (OPERATING ON THE PATIENT WITH A DEVICE MORE THAN 2 YEARS OLD) RESULTING IN DAMAGE BY THE USER OF THE DEVICE IN QUESTION. THE DELAY IN MDR SUBMISSION IS DUE TO EMPLOYEE TURNOVER IN THE QUALITY DEPARTMENT (INITIAL REPORT SUBMITTED ON 10/11/2022 VIA THE ESG PORTAL. HOWEVER, IT WAS LATER DISCOVERED THAT THE FORMAT USED WAS NOT ACCEPTED, SO THE REPORT HAS BEEN RE-SUBMITTED AT A LATER DATE).

    Description of Event or Problem · 0

    DURING THE LIPOSUCTION OPERATION, THE CANNULA USED BY THE SURGEON BROKE ON A CLEAN SECTION. THE PIECE OF THE CANNULA WAS RECOVERED REQUIRING A LARGER INCISION AND AN INCREASE IN OPERATING TIME. THE CANNULA BEEN USED BEYOND ITS RECOMMENDED LIFETIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823726 EUROMI REUSABLE CANNULA CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA EUROMI SA 1201LVITI-4300

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R