BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBE APC 300

    MDR report key: 1504905 · Received October 9, 2009

    Report

    Report Number
    9610614-2009-00022
    Event Type
    Other
    Date Received
    October 9, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 9, 2009
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM HAS BEEN DEEMED BY THE CUSTOMER TO BE FUNCTIONING AS INTENDED; THEREFORE, THE SYSTEM WAS NOT RETURNED TO ERBE FOR AN EVALUATION. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE INVOLVED DEVICES. IN CONCLUSION, NO EQUIPMENT PROBLEM OCCURRED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO TRENDS WERE IDENTIFIED WITH THE REPORTED SITUATION. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH THE INVOLVED STAFF ON (B)(6)2009 (I.E., TO REVIEW ARGON PLASMA COAGULATION BEING A NON-CONTRACT MODALITY AND MAKING SURE THAT SETTINGS ARE APPROPRIATE PRIOR TO ACTIVATION SO AS TO MINIMIZE ANY RE-OCCURRENCE OF THE INCIDENT IN THE FUTURE.). ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ERBE ARGON PLASMA COAGULATOR (APC) MODEL APC 300/ELECTROSURGICAL UNIT (ESU) MODEL ICC 200 E/A SYSTEM WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SYSTEM WAS USED IN A DOUBLE BALLOON ENDOSCOPY PROCEDURE TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS) IN A PATIENT'S COLON. HOWEVER, UPON ACTIVATION OF THE SYSTEM, A SMALL HOLE WITH A SUBMUCOSAL BLEB FORMED [NOTE: AT THAT TIME, THE STAFF REALIZED THAT THE FLOW SETTING WAS HIGHER THAN DESIRED (I.E., 2.0 LITERS/MINUTE RATHER THAN 1.0 LITER/MINUTE)]. NO PERFORATION OCCURRED PER A CT SCAN. NONETHELESS, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AND KEPT AT THE HOSPITAL FOR TWO DAYS FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 300 ARGON PLASMA COAGULATOR GEI ERBE ELECTROMEDIZIN GMBH APC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization