BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE FLEXIBLE CRYOPROBE

    MDR report key: 25016515 · Received April 28, 2026

    Report

    Report Number
    9610614-2026-00074
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOPROBE WAS RETURNED TO ERBE USA AND INSPECTED ON 04/08/26. THE VISUAL EXAMINATION REVEALED A SLIT OR CUT IN THE WHITE TUBING APPROXIMATELY 48MM LONG AND LOCATED 815MM FROM THE DISTAL END OF THE WHITE TUBING. THE BLACK TUBING WAS KINKED IN MULTIPLE LOCATIONS AND BROKE AT THE BLACK AND WHITE TUBING CONNECTION POINT. PER INSTRUCTIONS BY OUR MANUFACTURER, ERBE ELEKTROMEDIZIN GMBH, 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 SUFFICIENT. 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. PER ERBE ELEKTROMEDIZIN GMBH, IT APPEARS THAT THE CRYOPROBE ENCOUNTERED A SIGNIFICANT LATERAL FORCE (BETWEEN THE TUBING AND CONNECTOR) WHICH DISLODGED THE HIGH-PRESSURE TUBING FROM THE CONNECTOR WHICH CAUSED THE CRYOPROBE TO RUPTURE. PER THE CRYOPROBE'S NOTES ON USE (NOU) IT STATES, "PROTECT THIS PRODUCT FROM ANY FORM OF MECHANICAL DAMAGE! DO NOT THROW! DO NOT USE FORCE! NEVER USE EXCESSIVE FORCE WHEN INSERTING OR WITHDRAWING THE PRODUCT. OTHERWISE, THE PRODUCT COULD BECOME DAMAGED." IN CONCLUSION THOUGH, A DEFINITIVE DETERMINATION AS TO THE CAUSE OF THE RUPTURE CANNOT BE MADE. PER A REVIEW BY AN ERBE MEDICAL EXERT, THE RUPTURE OF THE CRYOPROBE OUTSIDE OF THE PATIENT COULDN'T HAVE CAUSED THE PATIENT'S PNEUMOTHORAX. ADDITIONALLY, A PNEUMOTHORAX IS A KNOWN PROCEDURE-RELATED RISK ASSOCIATED WITH LUNG BIOPSY. THE CUSTOMER IS BEING MADE AWARE OF THE FINDINGS. ERBE IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A FLEXIBLE CRYOPROBE DURING LUNG BIOPSIES. THE CRYOPROBE WAS USED WITH AN ERBE CRYOSURGICAL UNIT (MODEL ERBECRYO 2, PART NUMBER: 10402-000, SERIAL NUMBER: INFORMATION NOT PROVIDED) AND AN ION ROBOT. NO OTHER INFORMATION WAS PROVIDED REGARDING ANY OTHER ACCESSORY EMPLOYED DURING THE INCIDENT. PER THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE CRYOPROBE WAS TESTED IN SALINE AND IT FUNCTIONED PROPERLY. THEN, THERE WERE 3 SUCCESSFUL BIOPSIES/ACTIVATIONS (NOTE: THE CO2 TANK WAS AT 58 BAR AND ACTIVATION WERE 4 TO 5 SECONDS.). ON THE 4TH BIOPSY ATTEMPT, THE CRYOPROBE RUPTURED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT ENDED UP HAVING A PNEUMOTHORAX AND WAS TREATED ACCORDINGLY FOR THE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617983 ERBE FLEXIBLE CRYOPROBE CRYOPROBE GEH ERBE ELEKTROMEDIZIN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1