BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 24365517 · Received February 17, 2026

    Report

    Report Number
    9610614-2026-00030
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 17, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS NOT AVAILABLE FOR EVALUATION AS THE PROBE WAS DISCARDED. THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE RUPTURED PROBE WHICH REVEALED THERE WAS A SLIT/CUT IN THE WHITE TUBING. THIS IS INDICATIVE OF THE FAILURE MODE ERBE IS AWARE OF THAT IS CAUSED BY INSUFFICIENT GLUE APPLICATION BETWEEN THE CONNECTOR AND CLEAR THE PLASTIC TUBING. 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 BRONCHOSCOPY FOR 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) AT 55 BAR AND AN ION ROBOT. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY EMPLOYED DURING THE INCIDENT. PER THE ACCOUNT, WHEN THE PROBE WAS ACTIVATED, "THE TEAM HEARD A VERY LOUD HISSING SOUND, THEN AN EXTREMELY LOUD BANG. THE LOUD EXPLOSION DISRUPTED THE PROCEDURE AND CAUSED IMMEDIATE PAIN AND DISTRESS TO THE STAFF." A NEW CRYOPROBE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT INCIDENT. THE DOCTOR CONFIRMED THE PATIENT WAS SAFE WITH NO VISIBLE INJURY. THE TECHNICIANS AND DOCTOR EXPERIENCED EAR PAIN, RINGING IN THE EARS, AND ANXIETY. THE FACILITY SUBMITTED A MEDWATCH REPORT (NUMBER: (B)(4) TO THE AGENCY AND THEN THE REPORT WAS FORWARDED TO ERBE ON 01/27/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336511 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO462849

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other