BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 300 H

    MDR report key: 19805273 · Received July 23, 2024

    Report

    Report Number
    9610614-2024-00040
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K953738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. 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. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, (AS THE CUSTOMER SUSPECTED) THAT AFTER USING THE ALCOHOL DISINFECTANT (I.E., ASEPTODERM) ON THE PATIENT, IT WAS NOT COMPLETELY DRY AND THE ALCOHOLIC VAPORS HAD NOT YET EVAPORATED. THEN, DURING THE HF ACTIVATION (E.G., DUE TO THE INTENDED SPARK FORMATION AS PART OF THE COAGULATION/CUTTING FUNCTION OF THE TISSUE), COMBUSTION OCCURRED WHICH RESULTED IN A SMOLDERING FIRE AND THUS THE REPORTED BURN. THE EQUIPMENT'S USER MANUAL EXPRESSLY STATES THAT WHEN USING ANESTHETICS AND DISINFECTANTS, CARE MUST BE TAKEN TO ENSURE THAT THEY ARE NOT FLAMMABLE OR THAT THESE AGENTS HAVE EVAPORATED COMPLETELY AND BEEN REMOVED FROM THE AREA OF SPARKING AT LEAST BEFORE USING THE ELECTROSURGICAL UNIT. THE ASEPTODERM SAFETY DATA SHEET ALSO EXPLICITLY STATES THAT THE PRODUCT IS HIGHLY FLAMMABLE AND MUST NOT BE BROUGHT INTO CONTACT WITH OPEN FLAMES OR USED IN THE VICINITY OF IGNITION SOURCES. THIS ALSO APPLIES TO ANY INSTRUMENTS PLACED ON THE DRAPE/PATIENT THAT MAY STILL BE HOT AFTER ACTIVATION ON THE ELECTRODE. BASED UPON THE PROVIDED INFORMATION, A DEFECT IN THE ACCESSORIES IS VERY UNLIKELY TO HAVE CAUSED THE BURN. 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 WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING AN INTRAOPERATIVE ABSCESS REVISION ON THE RIGHT THIGH. THE ESU WAS USED WITH AN ERBE MONOPOLAR SLIM LINE ELECTRODE HANDLE [PART NUMBER (P/N) 20190-070, LOT NUMBER (L/N) INFORMATION NOT PROVIDED (NI)]. AN ERBE NEUTRAL ELECTRODE (NESSY PLATE 170, P/N 20193-070, L/N 230803-0805) WAS ATTACHED TO THE PATIENT'S LEFT FLANK. DURING THE PROCEDURE, A BURN OCCURRED ON THE PATIENT'S LEFT LOWER LEG. PER THE PROVIDED INFORMATION, A SMOULDERING FIRE HAD APPARENTLY OCCURRED ON THE DRAPE AROUND THE PATIENT'S LEFT LEG, PRESUMABLY DUE TO A COMBUSTION FROM THE DISINFECTANT THAT HAD NOT DRIED (SOAKED DRAPE). THE SKIN LESION WAS A SECOND-DEGREE BURN (WITH BLISTERING) OF APPROXIMATELY 100 CM² IN SIZE. DUE TO THE INCIDENT, THE WOUND WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964824 ERBE ICC 300 H ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 300 H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| O