BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 23853754 · Received December 19, 2025

    Report

    Report Number
    9610614-2025-00092
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS EVALUATED BY ERBE USA ON 2025-12-19. THE VISUAL EXAMINATION REVEALED A SLIT OR CUT IN THE WHITE TUBING APPROXIMATELY 18MM LONG AND LOCATED 183MM FROM THE DISTAL END OF THE WHITE TUBING. THEN AT THE DIRECTION OF THE MANUFACTURER, ERBE ELEKTROMEDIZIN GMBH (ERBE GERMANY), THE CRYOPROBE'S CONNECTOR SECTION WAS DISASSEMBLED AS INSTRUCTED. GLUE BETWEEN THE CONNECTOR AND THE CLEAR PLASTIC TUBING ON THE HIGH-PRESSURE SIDE OF THE CRYOPROBE WAS FOUND TO BE INSUFFICIENT. THE HIGH-PRESSURE TUBING WAS ALSO PUSHED OUT OF THE CONNECTOR. THE BLUE O-RING WAS STILL PRESENT, AND AN EXTRA BLACK O-RING WAS OBSERVED IN THE CONNECTOR. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT OF THE CRYOPROBE. 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 INSPECTION STEPS, INCLUDING A CAMERA-BASED PROCESS TO MONITOR THE GLUING OF EACH CRYOPROBE. ALL OF THESE MEASURES HAVE BEEN IMPLEMENTED TO MINIMIZE/ELIMINATE THE ISSUE. THE CUSTOMER IS BEING MADE AWARE OF THE FINDINGS. 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 PRIOR TO AN ENDOBRONCHIAL MASS DEBULKING. THE CRYOPROBE WAS USED WITH AN ERBE CRYOSURGICAL UNIT (MODEL ERBECRYO 2, PART NUMBER: 10402-000, SERIAL NUMBER: (B)(6). NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY EMPLOYED DURING THE INCIDENT. THE CRYOSURGICAL UNIT'S SETTINGS WERE EFFECT 1, AT 56 BAR. PER THE COMPLAINANT AND PRIOR TO THE PROCEDURE, THE PROBE WAS TESTED MAKING AN ICE BALL IN SALINE FOR APPROXIMATELY THREE (3) SECONDS ON THE FIRST ATTEMPT WHEN THE PROBE "POPPED AND MADE A VERY LOUD SOUND." IT WAS NOTED THAT THE "WHITE FLEXIBLE HOSE OF THE PROBE HAD BURST AND CAUSED A TEAR." THERE WAS NO REPORT OF ANY USER OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312078 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO462187

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown