BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 24454849 · Received February 26, 2026

    Report

    Report Number
    9610614-2026-00035
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 26, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS RETURNED TO ERBE GMBH FOR AN EVALUATION. THE VISUAL EXAMINATION REVEALED A TEAR IN THE WHITE PUR OUTER TUBING APPROXIMATELY 1.5CM LONG. THE EXAMINATION OF THE CRYOPROBE'S CONNECTOR REVEALED THAT THE ADHESIVE FOR CONNECTING THE INNER PA-TUBE IN POSITION WAS NOT APPLIED SUFFICIENTLY. THEREFORE, THE INNER PA-TUBE CAME LOOSE CAUSING A BYPASS BETWEEN THE SUPPLY AND RETURN LINES. SINCE THE RETURN LINE IS NOT DESIGNED FOR THIS AMOUNT OF GAS, A RUPTURE OF THE OUTER PUR-HOSE OCCURRED. ASSESSMENT BY ERBE GERMANY ERBE HAS BEEN MADE AWARE OF ISOLATED CASES WHERE THE OUTER WHITE TUBING OF CRYOPROBES RUPTURE. AFTER A THOROUGH INVESTIGATION, IT HAS BEEN CONCLUDED THAT A VERY LOW NUMBER OF ISOLATED INCIDENTS HAVE OCCURRED INVOLVING THE REPORTED FAILURE MODE. MORE SPECIFICALLY, LESS THAN 0.1% OF CRYOPROBES MANUFACTURED DURING THE TIMEFRAME WHICH THE PROBLEM WAS DISCOVERED HAVE RUPTURED. IN THESE RARE CASES, THE FIXATION OF THE GAS INLET INSIDE THE PROBE CONNECTOR HAD LOOSENED, ALLOWING GAS TO FLOW INTO THE RETURN LINE. SINCE THE RETURN LINE IS NOT DESIGNED FOR THIS VOLUME OF GAS, THE TUBING COULD RUPTURE. SINCE DISCOVERING THE ISSUE, THE MANUFACTURING PROCESS HAS BEEN IMPROVED BY STABILIZING THE ADHESIVE APPLICATION AND ADDING ADDITIONAL VISUAL INSPECTION STEPS TO MONITOR THE GLUING OF EACH CRYOPROBE. ALL OF THESE MEASURES HAVE BEEN IMPLEMENTED TO MINIMIZE/ELIMINATE THE ISSUE. ERBE USA, INC. IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A FLEXIBLE CRYOPROBE WHILE TESTING PRIOR TO A CRYOBIOPSY. THE CRYOPROBE WAS USED WITH AN ERBE CRYOSURGICAL UNIT (MODEL ERBECRYO 2, PART NUMBER: 10402-000, SERIAL NUMBER: INFORMATION NOT PROVIDED). NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY OR CRYOSURGICAL UNIT SETTINGS UTILIZED DURING THE INCIDENT. PER THE COMPLAINANT, THE CRYOPROBE BURST DURING TESTING BEFORE THE PROCEDURE. A REPLACEMENT CRYOPROBE WAS USED WITHOUT INCIDENT. THERE NO REPORTS OF PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609143 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO462677

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown