BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBECRYO 2 CRYOSURGICAL UNIT

    MDR report key: 24690784 · Received March 25, 2026

    Report

    Report Number
    9610614-2026-00059
    Event Type
    Death
    Date Received
    March 25, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CRYOSURGICAL UNIT OR CRYOPROBE WERE NOT AVAILABLE FOR AN EVALUATION. HOWEVER, THERE WERE NO REPORTS OF ANY EQUIPMENT OR ACCESSORY ISSUES/PROBLEMS DURING THE PROCEDURE. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE CRYOSURGICAL UNIT OR CRYOPROBE. IN CONCLUSION, NO ERBE EQUIPMENT/ACCESSORY PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE REPORTED EVENT. FOR EXAMPLE, THE PATIENT'S CONDITION, THE IN TOTO CRYOBIOPSY PROCEDURE, ETC. PER TRANSBRONCHIAL CRYOBIOPSY FOR THE DIAGNOSIS OF INTERSTITIAL LUNG DISEASES CHEST GUIDELINE AND EXPERT PANEL REPORT (2020): "5. IN PATIENTS WITH SUSPECTED ILD UNDERGOING TBC, WE SUGGEST THAT TBC BE PERFORMED WITH A BRONCHIAL BLOCKER EITHER THROUGH AN ENDOTRACHEAL TUBE OR RIGID BRONCHOSCOPE (UNGRADED CONSENSUS-BASED STATEMENT). REMARKS: IN THE CASE OF ENDOBRONCHIAL BLEEDING, PROPHYLACTIC PLACEMENT OF A BRONCHIAL BLOCKER ALLOWS FOR IMMEDIATE TAMPONADE WITHOUT FURTHER POSITIONING MANEUVER. WHILE WE ACKNOWLEDGE THAT TBC VIA RIGID BRONCHOSCOPY WITHOUT PROPHYLACTIC BALLOON PLACEMENT MAY BE CONSIDERED WHEN PERFORMED AT EXPERT CENTERS, THE SYSTEMATIC USE OF A BRONCHIAL BLOCKER IS SUGGESTED." FINALLY, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE(S) OF THE INCIDENT. 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 THE CRYOSURGICAL UNIT DURING A TRADITIONAL LARGE IN TOTO CRYOBIOPSY IN THE RIGHT LOWER LOBE OF THE LUNG (NOTE: AN ALTERNATIVE TO SURGICAL LUNG BIOPSY.). THE UNIT WAS USED WITH AN ERBE FLEXIBLE CRYOPROBE, 1.7 MM, L 1.15 M (PART NUMBER 20402-410, LOT NUMBER WO449141); OLYMPUS BRONCHOSCOPY VIDEO "TOWER", 190 SERIES OLYMPUS BRONCHOSCOPE (NOTE: ADDITIONAL TOOLS AVAILABLE ON A SIDE TABLE WERE COLD SALINE VIA LARGE SYRINGE, EPINEPHRINE MIXED SOLUTION VIA LARGE SYRINGE, AND A BALLOON BLOCKER.). THE CRYOSURGICAL UNIT WAS AT 57 BAR. PER THE REPORTED INFORMATION, THE PATIENT WAS VERY SICK AND HAD INTERSTITIAL LUNG DISEASE (ILD). ADDITIONALLY, THE PATIENT HAD BEEN IN THE HOSPITAL IN ICU AND WAS UNCONSCIOUS ON A VENTILATOR FOR FIVE (5) DAYS PRIOR TO THE CRYOBIOPSY PROCEDURE. DURING THE BRONCHOSCOPY A TISSUE SPECIMEN, WHICH APPEARED TO BE CLEAN AND BLOODLESS, WAS OBTAINED AND REMOVED FROM THE PATIENT. HOWEVER, BLEEDING OCCURRED. VARIOUS METHODS WERE EMPLOYED TO MANAGE THE BLEEDING AND STABILIZE THE PATIENT. NEVERTHELESS, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751816 ERBECRYO 2 CRYOSURGICAL UNIT CRYOSURGICAL UNIT GEH ERBE ELEKTROMEDIZIN GMBH ERBECRYO 2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death