BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL SYSTEM

    MDR report key: 3181926 · Received June 17, 2013

    Report

    Report Number
    1216677-2013-00018
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LL100 CRYO GUN WAS THOROUGHLY INVESTIGATED BY OUR SVC AND REPAIR DEPT AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE UNIT TESTED TO SPECIFICATION AND THE TIP WOULD NOT COME OFF. PLEASE NOTE - THE ONLY WAY THE TIP COULD COME OFF IS IF IT WAS NOT SCREWED ONTO THE SHAFT PROPERLY. THE THREADS WERE NOTED TO BE IN PERFECT CONDITION. (B)(4).

    Description of Event or Problem · 1

    DOCTOR WAS DEMONSTRATING THE CRYO GUN AND THE TIP BLEW OFF - IT DID NOT IMPACT ANYONE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274336 LL100 CRYOSURGICAL SYSTEM CRYO GUN GEH COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1