BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 24482562 · Received March 2, 2026

    Report

    Report Number
    9610614-2026-00039
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS EVALUATED BY ERBE USA ON 2026-02-27. THE VISUAL EXAMINATION REVEALED THAT THERE WAS A SLIT OR CUT IN THE WHITE TUBING APPROXIMATELY 48MM LONG AND LOCATED 815 MM 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, AND THE BLUE O-RING WAS STILL PRESENT. 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 VISUAL INSPECTION STEPS 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 DURING A PERIPHERAL LUNG NODULE BIOPSY. THE CRYOPROBE WAS USED WITH AN ERBE CRYOSURGICAL UNIT (MODEL ERBECRYO 2, PART NUMBER: 10402-000, SERIAL NUMBER: NOT PROVIDED) AND AN ION ROBOT. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY EMPLOYED DURING THE INCIDENT. THE SETTING WAS 56 BAR. PER THE REPORT, PRODUCT RUPTURED DURING THE INITIAL ACTIVATION (I.E., APPROXIMATELY 4 SECONDS OF INITIAL FREEZE TIME WITH ADDITIONAL ACTIVATION DURING EXTRACTION OF CRYOPROBE AND TISSUE FROM ROBOTIC BRONCHOSCOPE FOR A TOTAL ACTIVATION TIME OF ABOUT 10 SECONDS.). SPECIFICALLY, THE HOSE PORTION OF CRYOPROBE ABRUPTLY "EXPLODED." THERE WAS NO REPORT OF ANY INJURY TO THE STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546665 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO463403

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown