BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASMUTH

    MDR report key: 22725078 · Received August 6, 2025

    Report

    Report Number
    8020045-2025-00019
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 10, 2025
    Report Date
    September 10, 2025
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    29005531500475
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. AFTER REQUESTING FURTHER INFORMATION REGARDING THE SPECIFIED SPARKING, WE HAVE BEEN INFORMED THAT: "THE MANUFACTURER OF THE GENERATOR HAS INVESTIGATED THE USED ELECTROSURGICAL UNIT AND FOUND NO MALFUNCTION. THE SAFETY INSPECTION CONFIRMED THE FUNCTIONALITY AND SAFETY OF THE DEVICE. THE MANUFACTURER ASSUMES THAT THE SKIN MAY NOT HAVE BEEN COMPLETELY DRIED AFTER DISINFECTION WITH ALCOHOL-BASED DISINFECTANT, OR THAT ALCOHOL-BASED DISINFECTANT (OCTENISEPT) MAY HAVE ACCUMULATED IN THE MOLTEX CLOTH AND THE ALCOHOL VAPORS HAD NOT YET EVAPORATED. THE SUBSEQUENT HF APPLICATION (E.G., DUE TO THE INTENDED SPARKING DURING THE COAGULATION/CUTTING FUNCTION OF THE TISSUE) SUBSEQUENTLY LED TO THE FIRE/FLAME FORMATION. THE GENERATOR'S INSTRUCTIONS FOR USE CONTAIN CORRESPONDING INFORMATION THAT WHEN USING ANESTHETICS AND DISINFECTANTS, CARE MUST BE TAKEN TO ENSURE THAT THEY ARE NON-FLAMMABLE AND THAT THESE AGENTS HAVE COMPLETELY EVAPORATED AND REMOVED FROM THE AREA OF SPARKING BEFORE USING THE ELECTROSURGICAL UNIT." WE THEREFORE CONCLUDE THAT THE DISPERSIVE NEUTRAL ELETRODE MANUFACTURED BY LEONHARD LANG HAS NOT CAUSED OR CONTRIBUTED TO THE EVENT OR THE PATIENT INJURY AND CLOSE OUT THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS WERE DETECTED. WE HAVE REQUESTED FURTHER INFORMATION, A QUESTIONNAIRE TO BE COMPLETED AND THE INVOLVED DEVICE BUT HAVE NOT RECEIVED ANY SO FAR. NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED INCIDENT. WE WILL THEREFORE PROVIDE A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A MONITORING DISPERSIVE ELECTRODE ASMUTH NEUTRAL ELECTRODE CATALOGUE REF.: (B)(4) OUR MODEL WR21 AND AN ERBE VIO 300D ESU GENERATOR AT HOSPTIAL IN (B)(6). THE INITIAL REPORTER INFORMED US: "DURING THE ANAL FISTULA SURGERY AT AROUND 10:40 A.M., SPARKS IGNITED FLAMMABLE BODY GASES. THIS IGNITED THE MOLTEX. THE PATIENT WAS IN THE LITHOTOMY POSITION AND SUFFERED 2A BURNS TO HIS THIGHS FROM THE FIRE. A NEUTRAL ELECTRODE FROM ASMUTH ASNE02 LOT 241212-4703 WAS USED. THE PATIENT WAS LYING ON AN OPERATING TABLE AND PLATE FROM TRUMPF MODEL JUPITER (B)(6)." WE HAVE REQUESTED FURTHER DETAILS FOR CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE AND HAVE RECEIVED A FILLED IN QUESTIONAIRE. A 10MINUTES ANAL FISTULA SURGERY TO REMOVE THE FISTULA WAS PERFORMED. THE PATIENT WAS DESCRIBED AS OF NORMAL BODY TYPE, WITH "HAIRY SKIN, NORMAL". NO INFORMATION WAS PROVIDED ON THE PATIENT'S SKIN PREPARATION. THE PATIENT WAS LYING IN THE LITHOTOMY POSITION AND THE DISPERSIVE ELECTRODE WAS PLACED ON THE LOWER UPPER RIGHT THIGH. IT WAS STATED THAT UNDERNEATH THE DISPERSIVE ELECTRODE HAD BEEN HAIRS VISIBLE. THE GENERATOR SETTINGS HAVE BEEN DESCRIBED AS CUT 3 AND COAGULATION 3. IT WAS ALSO REPORTED THAT "SPARKING DURING COAGULATION" TRIGGERED THE INCIDENT. THE PATIENT EXPERIENCED A 2ND DEGREE BURN. THE BURN WAS TREATED "CONSERVATIVELY USING OINTMENT AND BANDAGE".

    Description of Event or Problem · 0

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A MONITORING DISPERSIVE ELECTRODE ASMUTH NEUTRAL ELECTRODE CATALOGUE REF.: ASNE02 OUR MODEL WR21 AND AN UNKOWN ESU GENERATOR AT HOSPTIAL IN (B)(6). THE INITIAL REPORTER INFORMED US: "DURING THE ANAL FISTULA SURGERY AT AROUND 10:40 A.M., SPARKS IGNITED FLAMMABLE BODY GASES. THIS IGNITED THE MOLTEX. THE PATIENT WAS IN THE LITHOTOMY POSITION AND SUFFERED 2A BURNS TO HIS THIGHS FROM THE FIRE. A NEUTRAL ELECTRODE FROM ASMUTH ASNE02 LOT 241212-4703 WAS USED. THE PATIENT WAS LYING ON AN OPERATING TABLE AND PLATE FROM TRUMPF MODEL JUPITER (B)(6)." WE HAVE REQUESTED FURTHER DETAILS FOR CUSTOMER SAMPLES AND A FILLED IN QUESTIONNAIRE. NO FURTHER DETAILS HAVE BEEN RECEIVED SO FAR DESPITE REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555950 ASMUTH ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH WR21 29005531500475

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention