BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZEE RETRIEVAL

    MDR report key: 10250247 · Received July 9, 2020

    Report

    Report Number
    3002590791-2020-00030
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    April 18, 2018
    Report Date
    July 8, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED IN A REVIEW OF COMPLAINT FILES DATED BETWEEN (B)(6) 2017 AND (B)(6) 2019. A ROOT CAUSE OF THE MALFUNCTION WAS NOT DETERMINED DURING THE EVALUATION OF THE SAMPLE OR PRODUCTION RECORDS.

    Description of Event or Problem · 1

    THE PRODUCT TORE/BROKE AS THE SURGEON WAS PULLING THE GALLBLADDER OUT OF THE PATIENT. THE SURGEON WAS PERFORMING A LAP CHOLE PROCEDURE; THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715968 EZEE RETRIEVAL SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 500-000-000 I8920

    Patients

    Seq Age Sex Outcome Treatment
    1