BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBECRYO 2

    MDR report key: 10395220 · Received August 12, 2020

    Report

    Report Number
    9610614-2020-00025
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEH
    PMA / PMN Number
    K190651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRYOSURGICAL UNIT WAS THOROUGHLY INSPECTED/TESTED [NOTE: THE SINGLE USE CRYOPROBE WAS DISCARDED AND NOT AVAILABLE FOR AN EVALUATION. IT WAS REPORTED THOUGH THAT THE PROBE WORKED WELL AND FORMED AN ICE BALL AS INTENDED WITHOUT LEAKING.]. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE CRYOSURGICAL UNIT'S DEVICE HISTORY RECORD (DHR) [NOTE: THE DHR FOR THE CRYOPROBE DEMONSTRATED THAT THE PROBE PASSED LEAK TESTING.]. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE DESCRIPTION OF THE EVENT AND A REVIEW OF LITERATURE, INJURIES TO LUNG PARENCHYMA CAN LEAD TO A GAS EMBOLISM WHICH COULD CAUSE CARDIAC ARREST. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE CRYOSURGICAL UNIT DURING A BIOPSY IN THE TRACHEOBRONCHIAL TREE. THE UNIT WAS USED WITH A SINGLE USE CRYOPROBE (PART NUMBER 20402-401, LOT NUMBER WO315706). DURING THE PROCEDURE, AN EMBOLISM OCCURRED AND THE PATIENT WENT INTO CARDIAC ARREST. THROUGH EMERGENCY TREATMENT, THE PATIENT WAS REVIVED. NOTE: THE UNIT AND CRYOPROBE WERE DISTRIBUTED TO A MEDICAL CENTER IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861048 ERBECRYO 2 CRYOSURGICAL UNIT AND ACCESSORIES GEH ERBE ELEKTROMEDIZIN GMBH ERBECRYO 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R