BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 14110690 · Received April 14, 2022

    Report

    Report Number
    9610614-2022-00009
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    January 20, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE INCIDENT, THE HOSPITAL'S TECHNICAL TEAM PERFORMED A SAFETY INSPECTION ON THE COAGULATOR. ACCORDING TO HOSPITAL PERSONNEL, THE APC WAS FUNCTIONAL AND SAFE. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE APC. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. BASED UPON THE INFORMATION PROVIDED, IT APPEARS COMBUSTIBLE GASES (E.G., METHANE AND/OR HYDROGEN) WERE AT SUCH A CONCENTRATION IN THE BOWEL THAT WHEN DIATHERMY WAS APPLIED AN EXPLOSION OCCURRED. ALTHOUGH VERY RARE THE COMPLICATION CAN OCCUR. THEREFORE THERE IS A WARNING IN THE ERBE USER MANUALS, "FLAMMABLE ENDOGENOUS GASES IN THE GASTROINTESTINAL TRACT, RISK OF EXPLOSION TO THE PATIENT!, EXTRACT THE GASES BEFORE PERFORMING ELECTROSURGERY OR IRRIGATE WITH CO2". ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. NO INFORMATION WAS PROVIDED IN REGARDS TO THE INVOLVED ERBE ESU OR PROBE. NEVERTHELESS, IT WAS STATED THAT AN ERBE APC/ESU SYSTEM WAS USED IN A SIGMOIDOSCOPY TO STOP RECTAL BLEEDING. UPON ACTIVATING THE COAGULATOR, THERE WAS A LOUD BANG IN THE BOWEL. THEREFORE, THE ENDOSCOPE WITH THE PROBE WERE IMMEDIATELY WITHDRAWN FROM THE PATIENT'S BOWEL. A SUPERFICIAL BURN OCCURRED ON THE PATIENT'S RECTAL MUCOSA AND NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145620 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other