BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICC 200

    MDR report key: 1961531 · Received December 29, 2010

    Report

    Report Number
    1961531
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    October 4, 2010
    Report Date
    December 27, 2010
    Manufacturer
    ERBE USA INCORPORATED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING COLONOSCOPY. A 1 CM SESSILE POLYP WAS IDENTIFIED IN THE PROXIMAL ASCENDING COLON CLOSE TO THE CECUM. THE PHYSICIAN PLANNED TO REMOVE IT IN TWO PIECES. THE SNARE WAS PLACED OVER THE DISTAL ASPECT OF THE POLYP. CARE WAS TAKEN TO ENSURE NOT TOO MUCH WAS GRABBED. THE POLYP WAS QUITE SOFT. SNARE POLYPECTOMY WAS PERFORMED. THE UNIT WAS SET ON THE STANDARD SETTING FOR CAUTERY AND COAGULATION, 150/30 EFFECT 3 WHICH IS A BLENDED CAUTERY SETTING. WHEN THE PHYSICIAN STEPPED ON THE YELLOW PEDAL AND THE CAUTERY WAS APPLIED, IT APPEARED THAT MORE CAUTERY THAN USUAL OCCURRED AND THE MACHINE DID NOT MAKE THE USUAL SOUNDS THAT IT MAKES DURING POLYPECTOMY. THE PHYSICIAN QUICKLY AND IMMEDIATELY TOOK HIS FOOT OFF THE PEDAL. A SECOND ERBE ELECTROCAUTERY DEVICE WAS MOVED INTO POSITION AND THE PARTIAL POLYPECTOMY WAS COMPLETED. AN ATTEMPT WAS MADE TO GATHER THE REMAINDER OF THE POLYP BUT IT WAS DIFFICULT TO DO AS WHENEVER AN ATTEMPT TO SNARE IT WAS MADE THE PREVIOUSLY CAUTERIZED SITE WAS COLLECTED. THERE APPEARED TO BE NO OTHER INDICATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICC 200 ELECTROSURGICAL GENERATOR GEI ERBE USA INCORPORATED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR