BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 350 E

    MDR report key: 6010693 · Received October 7, 2016

    Report

    Report Number
    9610614-2016-00026
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. IN CONCLUSION, NO PROBLEM WAS FOUND WITH THE GENERATOR THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE FLASH FIRE IN THE AIRWAY APPEARS TO HAVE BEEN CAUSED BY IMPROPER OXYGEN MANAGEMENT. THE POTENTIAL OF THIS COMPLICATION IS WELL DOCUMENTED IN PUBLISHED LITERATURE AND IS WIDELY KNOWN IN THE MEDICAL COMMUNITY. ADDITIONALLY, THERE ARE WARNINGS REGARDING THIS TYPE OF ISSUE IN OUR USER MANUAL. 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 ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A BRONCHOSCOPY. THE ESU WAS BEING USED WITH AN OLYMPUS HOT BIOPSY FORCEPS TO ABLATE A TUMOR. NO FURTHER DETAILS PROVIDED ON THE NON-ERBE ACCESSORY. THE GENERATOR SETTINGS WERE MOST LIKELY SPRAY COAG, 40 WATTS. WHILE ACTIVATING, A FLAME OCCURRED AT THE INSTRUMENT INTRAOPERATIVE WHICH RESULTED IN A MUCOSAL LESION. THE MEDICAL PERSONNEL REDUCE THE OXYGEN CONCENTRATION FROM 100% TO 70%. TO TREAT THE MUCOSAL NECROSIS, THE PATIENT WAS ADMINISTERED A STEROID INHALANT, PULMICORT. NOTE: THE GENERATOR IS A SIMILAR UNIT THAT WAS DISTRIBUTED IN THE U.S. THE ESU WAS DISTRIBUTED TO A HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662652 ERBOTOM ICC 350 E ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 350 E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention