BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYO PROBE

    MDR report key: 7397190 · Received April 4, 2018

    Report

    Report Number
    9610614-2018-00005
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 4, 2018
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K051509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRYO PROBE WAS RETURNED AND THOROUGHLY EVALUATED. THE COMPLAINT THAT THE PROBE RUPTURED WAS VERIFIED AS REPORTED. OUR INVESTIGATION REVEALED THAT THE THREADED HOSE COUPLING FOR THE GAS SUPPLY DISCONNECTED AT THE CONNECTOR END OF THE ACCESSORY, CAUSING GAS TO ESCAPE INTO THE GREY TUBING AND EVENTUALLY, IT RUPTURING. NO DETERMINATION COULD BE MADE AS TO WHAT CAUSED THE INTERNAL PARTS TO DETACH FROM EACH OTHER. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, THE CUSTOMER WILL BE ADVISED TO INSPECT/TEST CRYO PROBES PRIOR TO USE AS WELL AS HAVE PROBES TESTED ONCE A YEAR PER THE NOTES ON USE. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A INCIDENT OCCURRED WITH THE FLEXIBLE CRYO PROBE. SPECIFICALLY, DURING A PROCEDURE, THE HOSE OF THE ACCESSORY RUPTURED AND THE LOUD SOUND AFFECTED THE DOCTOR'S HEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237881 ERBE FLEXIBLE CRYO PROBE FLEXIBLE CRYO PROBE GEH ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other