BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 24019130 · Received January 9, 2026

    Report

    Report Number
    9610614-2026-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PUR TUBING APPROXIMATELY 1.7CM LONG AND LOCATED 34CM PROXIMAL TO THE GAS DIVERTER. THE DISTAL END WAS KINKED. THE EXAMINATION OF THE CRYOPROBE'S CONNECTOR REVEALED THAT THE ADHESIVE FOR FIXING 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 LEADING TO THE RUPTURE OF THE OUTER PUR-HOSE. 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. 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, AFTER THE SECOND BIOPSY AND PRESSING THE UNIT'S FOOTSWITCH PEDAL, A "LOUD BANG" OCCURRED. SPECIFICALLY, IT CAUSED "BANG TRAUMA" FOR EVERYONE PRESENT IN THE ROOM. AN ENT CONSULTATION IS PLANNED, BUT NO FURTHER DETAILS OR CONSEQUENCES OF THE INCIDENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78493 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH WO463315

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female