BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 23866684 · Received December 22, 2025

    Report

    Report Number
    9610614-2025-00096
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE HAS NOT YET BEEN RETURNED FOR AN EVALUATION. HOWEVER, BASED UPON SIMILAR REPORTED EVENTS, IT APPEARS THAT THE ACCESSORY'S FAILURE WAS DUE TO A MANUFACTURING DEFECT (NOTE: SEE ASSESSMENT BY ERBE GERMANY). HOWEVER, NO CONCLUSIVE DETERMINATION CAN BE MADE AS TO THE CAUSE SINCE THE DEVICE HAS NOT YET BEEN INSPECTED. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT OF THE CRYOPROBE. IF THE DEVICE IS RETURNED AND EXAMINED, AND ANOTHER DETERMINATION IS MADE AS TO THE CAUSE OF THE EVENT BESIDES A MANUFACTURING DEFECT, A FOLLOW-UP REPORT WILL BE FILED. 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 A POLYPECTOMY. 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 EMPLOYED DURING THE INCIDENT OR THE CRYOSURGICAL UNIT'S SETTINGS. PER THE COMPLAINANT, THE CRYOPROBE WAS TESTED PRIOR TO THE PROCEDURE WHEN A HISSING SOUND WAS OBSERVED. TESTING WAS STOPPED AND NURSE UNPLUGGED THE PROBE TO CONFIRM AN ABSOLUTE CONNECTION. THE PHYSICIAN ATTEMPTED TO TEST THE PROBE AGAIN AND UPON IMMEDIATE ACTIVATION THE PROBE "POPPED", AND IT WAS NOTED THAT IT SOUNDED LIKE A "GUN WENT OFF." THERE WAS NO REPORT OF ANY INJURY TO THE PATIENT OR THE MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591958 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO462845

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown