BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 25149605 · Received May 12, 2026

    Report

    Report Number
    9610614-2026-00085
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Removal / Correction Number
    1057212-02242026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS RETURNED TO ERBE USA AND INSPECTED ON 05/12/26. THE VISUAL EXAMINATION REVEALED A SLIT OR CUT IN THE WHITE TUBING APPROXIMATELY 15MM LONG AND LOCATED 45MM FROM THE DISTAL END OF THE WHITE TUBING. PER INSTRUCTIONS BY OUR MANUFACTURER, ERBE ELEKTROMEDIZIN GMBH, THE CRYOPROBE'S CONNECTOR SECTION WAS DISASSEMBLED. GLUE BETWEEN THE CONNECTOR AND THE CLEAR PLASTIC TUBING ON THE HIGH-PRESSURE SIDE OF THE CRYOPROBE WAS PRESENT. THE HIGH-PRESSURE TUBING WAS ALSO PUSHED OUT OF THE CONNECTOR, AND THE BLUE O-RING WAS STILL A PART OF THE DEVICE. IN ADDITION, THERE WAS A BEND IN THE BLACK TUBING. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT OF THE CRYOPROBE. THE INSPECTION RESULTS AND PHOTOGRAPHIC IMAGERY WERE PROVIDED TO THE MANUFACTURER, ERBE ELEKTROMEDIZIN GMBH, FOR THEIR REVIEW. IT APPEARS THAT DESPITE THE HIGH-PRESSURE TUBING BEING GLUED IN THE CONNECTOR, IT ENCOUNTERED A PULL FORCE THAT CAUSED IT TO BECOME DISLODGED. NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO WHEN THE TUBING BECAME DISLODGED. THE CRYOPROBE LOT IS A PART OF AN EXPANDED RECALL. CURRENT CRYOPROBES NOW INCLUDE A COMPONENT THAT MITIGATES THE POSSIBILITY OF RUPTURE. THE CUSTOMER IS BEING MADE AWARE OF THE FINDINGS. ERBE IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A FLEXIBLE CRYOPROBE DURING A CRYOBIOPSY PROCEDURE TO REMOVE A LUNG LESION. THE CRYOPROBE WAS USED WITH AN ERBE CRYOSURGICAL UNIT (MODEL ERBECRYO 2, PART NUMBER: 10402-000, SERIAL NUMBER: INFORMATION NOT PROVIDED) AND ROBOTIC BRONCHOSCOPE. THE UNIT'S SETTINGS WERE EFFECT 1. THE CRYOPROBE WAS TESTED PRIOR TO THE PROCEDURE AND THERE WERE NO ISSUES. THEN, THEY WERE SUCCESSFUL IN OBTAINING AN INITIAL BIOPSY SPECIMEN. HOWER DURING THE SECOND PASS, THE CRYOPROBE RUPTURED. SPECIFICALLY, IT WAS REPORTED THAT UPON STEPPING ON THE CRYOSURGICAL UNIT'S FOOTSWITCH PEDAL, THERE WAS A LOUD GUNSHOT SOUND. IMMEDIATELY, THE DOCTOR COVERED HIS HEAD AND WENT TO THE GROUND IN FEAR. THEY THEN NOTICED A BREAK IN THE WHITE CATHETER 2 INCHES FROM WHERE THE WHITE JOINS THE BLACK PART OF CRYOPROBE. THERE WAS NO REPORT OF ANY STAFF OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377014 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO472600

    Patients

    Seq Age Sex Outcome Treatment
    1