BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 3739173 · Received March 11, 2014

    Report

    Report Number
    1216677-2014-00003
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 11, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE STATED COMPLAINT. THE DEVICE INVOLVED IN THE COMPLAINT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVAL. ONCE THE DEVICE IS RECEIVED BY COOPERSURGICAL INC. THE INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE TIP "FLEW OFF" DURING A PROCEDURE. THERE WAS NO INJURY TO THE PT OR TO THE PROVIDERS IN THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146259 LL100 CRYOSURGICAL CRYO-GUN GEH COOPERSURGICAL, INC. LL100

    Patients

    Seq Age Sex Outcome Treatment
    1