BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE CRYO PROBE

    MDR report key: 3958149 · Received July 18, 2014

    Report

    Report Number
    9610614-2014-00010
    Event Type
    Death
    Date Received
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K051509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT PROBLEMS WERE REPORTED IN THE STUDY. THE ARTICLE STATED "THESE PRELIMINARY RESULTS, SHOW THAT THE TECHNIQUE APPEARS TO BE SAFER THAN SURGICAL LUNG BIOPSY, BUT NOT HARMLESS. AMONG 113 CASES COLLECTED TO DATE AT OUR CENTRE, ONE DIED (0.9%) AND THIS LEAD US TO THE CONCLUSION THAT BEFORE THIS TOOL IS WIDELY ADOPTED WE NEED TO TEST ITS SAFETY IN LARGER MULTICENTRIC TRIALS." IN GENERAL IT APPEARED THAT THE DEATH AND ALL OF THE REPORTED COMPLICATIONS WERE A RESULT OF THE DISEASE STATE OF THE PATIENTS. HOWEVER, NO CONCLUSIVE DETERMINATION CAN BE MADE. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    DURING A REVIEW OF A CLINICAL STUDY IN CRYOBIOPSY IN INTERSTITIAL LUNG DISEASES, FEBRUARY 2014, VOLUME 9, ISSUE 2, E86716; TRANSBRONCHIAL LUNG CRYOBIOPSY IN THE DIAGNOSIS OF FIBROTIC INTERSTITIAL LUNG DISEASES; A DEATH WAS DOCUMENTED. PER THE ARTICLE, AN ERBE (B)(4)CRYOPROBE (2.4 MM DIAMETER X 90 CM LENGTH) WAS USED IN THE PROCEDURES (NOTE: OTHER COMPLICATIONS WERE ALSO REPORTED). THE STUDY WAS INVESTIGATING CRYOBIOPSY TO DIAGNOSIS FIBROTIC INTERSTITIAL LUNG DISEASES. THE CLINICAL LITERATURE REPORTED THAT A PATIENT DIED OF ACUTE EXACERBATION OF IDIOPATHIC PULMONARY FIBROSIS (IPF) 7 DAYS AFTER THE PROCEDURE. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423315 ERBE CRYO PROBE CRYO PROBE GEH ERBE ELEKTROMEDIZIN GMBH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death