BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE SPECIMEN RETRIEVAL BAG

    MDR report key: 10368332 · Received August 5, 2020

    Report

    Report Number
    3002590791-2020-00087
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    June 20, 2019
    Report Date
    August 5, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINT FILES BETWEEN OCTOBER 2017 THROUGH DECEMBER 2019. REFER TO COMPLAINT FILE R19037 REV. 1. THIS REPORT IS FOR THE 4TH DEVICE LISTED IN THE COMPLAINT.

    Description of Event or Problem · 1

    THE BAG BROKE INSIDE OF THE PATIENT. THE SURGEON HAD TO SPEND 30 MINUTES RETRIEVING THE SPECIMEN FROM PATIENT. THE SURGICAL TECHS ALSO SAID THAT 3-4 BAGS HAD BROKEN THE WEEK BEFORE IN THE TROCAR. UPON INVESTIGATION WITH THE STAFF, THE BAGS HAVE BROKEN 3-4 OTHER TIMES OVER THE COURSE OF A COUPLE OF WEEKS. THESE BAGS DID NOT BREAK INSIDE THE PATIENT, HOWEVER THEY DID BREAK DURING BAG REMOVAL THROUGH THE DEFECT AFTER THE TROCAR WAS REMOVED. ALL BAG BREAKS WERE AT THE BOTTOM OF THE BAG. IT WAS STATED THAT "IT WASN'T SO MUCH OF A TEAR, BUT THE BAG POPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831200 GENICON 2EZEE SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200

    Patients

    Seq Age Sex Outcome Treatment
    1