BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 300

    MDR report key: 6200926 · Received December 22, 2016

    Report

    Report Number
    9610614-2016-00033
    Event Type
    Death
    Date Received
    December 22, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. IN ADDITION, A THOROUGH INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED ON THE UNITS. NO ISSUES WERE FOUND. ALSO, THE GAS FLOW RATES WERE MEASURED AND FOUND TO BE WITHIN THEIR ACCEPTABLE RANGES FOR THE APC. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENTS. HOWEVER IT APPEARS THAT DURING THE INTERVENTION WORK ON THE PATIENTS, THE REMAINING WALL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION IN BOTH SUBJECTS. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENTS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK TOOK PLACE WITH THE MEDICAL PERSONNEL ON 12/08/2016. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) /ELECTROSURGICAL UNIT (ESU/GENERATOR, PART NUMBER 10128-205, SERIAL NUMBER (B)(4)) WAS INVOLVED IN TWO (2) PATIENT INCIDENTS DURING THE WEEK OF (B)(6) 2016. THE APC WITH A FILTER INTEGRATED (FI) APC PROBE WAS USED IN BOTH PROCEDURES. THE SAME DOCTOR WAS INVOLVED . THE SETTING WAS ARGON (A), 40 WATTS. PERFORATIONS OCCURRED WITH BOTH PATIENTS. SURGICAL INTERVENTION WAS REQUIRED. ONE RECOVERED AND THE OTHER DIED AFTER OR DURING SURGERY. NO FURTHER INFORMATION WAS MADE AVAILABLE REGARDING THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850841 ERBE APC 300 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L