BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE ERBECRYO 2

    MDR report key: 18796655 · Received February 28, 2024

    Report

    Report Number
    9610614-2024-00016
    Event Type
    Death
    Date Received
    February 28, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT AND THE CRYOPROBE WERE NOT RETURNED TO ERBE FOR AN EVALUATION. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE PATIENT INCIDENT. HOWEVER, IN THIS CASE, THE PATIENT'S AGE (I.E., BEING ELDERLY) AND DISEASE STATE (I.E., HAVING CANCER) WERE SIGNIFICANT CIRCUMSTANCES INVOLVED IN THE EVENT. BLEEDING UPON A BIOPSY IS EXPECTED AND A KNOWN COMPLICATION. THE SEVERITY OF THE BLEEDING DEPENDS ON MANY FACTORS. NEVERTHELESS, THE CRYOPROBE'S NOTES ON USE EXPLICITLY STATES THAT BLEEDING AND INFLAMMATION CAN OCCUR AS WELL AS LARGE VESSELS CAN BE DAMAGED. IN CONCLUSION, THE SPECIFIC CAUSE(S) OF THE BLEED IS NOT KNOWN. NO TRENDS HAVE BEEN IDENTIFIED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED DURING A BRONCHOSCOPY WITH CRYOBIOPSY. THE CRYOSURGICAL UNIT/SYSTEM WAS BEING USED WITH AN ERBE CRYOPROBE (PART NUMBER 20402-401, LOT NUMBER INFORMATION NOT PROVIDED). THE ERBE EQUIPMENT AND ACCESSORY WERE USED IN CONJUNCTION WITH A MEDTRONIC GUIDING SHEATH AND NAVIGATION SYSTEM. THE BRONCHOSCOPE AND GUIDING SHEATH WERE TIGHTLY CLAMPED THROUGHOUT THE PROCEDURE (NOTE: THE PATIENT WAS UNDER ENDOTRACHEAL INTUBATION.). A MANUAL FREEZING TIME OF 3 TO 4 SECONDS WAS SELECTED. PERIPHERAL LESIONS WERE BEING BIOPSIED DUE TO A KNOWN BREAST CANCER DIAGNOSIS AND SUSPECTED METASTASES. PRESUMABLY AT A BIOPSY REMOVAL SITE, MAJOR BREEDING OCCURRED (NOTE: THE SAMPLE SIZE WAS SMALL.). THEN, THERE WAS A DROP IN OXYGEN SATURATION AND BLOOD WAS DETECTED IN THE ENDOTRACHEAL TUBE. TO ADDRESS THE ISSUES, AN ICE-COLD SALINE SOLUTION AND ADRENALINE WAS ADMINISTERED USING TAMPONADE AND A CLOT WAS REMOVED. AFTER ABOUT 20 MINUTES, THE BLEEDING STOPPED WITH THE ASSISTANCE OF AN ENDOBRONCHIAL BLOCKER. THE PATIENT WAS THEN INTUBATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT SUBSEQUENTLY DEVELOPED ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) WITH PNEUMONIA AND SEPTIC SHOCK. DUE TO THE ILLNESS, THE PATIENT DIED. ACCORDING TO THE USER, THERE WAS NO CONNECTION BETWEEN THE BLEEDING AFTER THE BIOPSY REMOVAL AND THE SEPTIC SHOCK OR DEATH OF THE PATIENT. SPECIFICALLY, THE CAUSE OF DEATH WAS SEPTIC SHOCK DUE TO THE PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741647 ERBE ERBECRYO 2 CRYOSURGICAL UNIT GEH ERBE ELEKTROMEDIZIN GMBH ERBECRYO 2

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Life Threatening| H| R| D