BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 2780671 · Received October 2, 2012

    Report

    Report Number
    9610614-2012-00014
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    August 20, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTROSURGICAL UNIT (ESU) HAS BEEN RETURNED AND CURRENTLY IS BEING INSPECTED/TESTED. UPON COMPLETION OF THE EVAL, A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED VIA A MEDWATCH (NUMBER (B)(4)) THE FOLLOWING: "I PLACED A HEMOSTATIC CLIP PRE-RESECTION ACROSS PART OF THE STALK. I STARTED PIECEMEAL RESECTIONING USING A SNARE AND AN ERBE VIO ELECTROCAUTERY UNIT. ON THE FIRST BITE I ATTEMPTED 'CONDITIONING' USING PURE COAGULATION TO DECREASE RISK OF BLEEDING WAS ATTEMPTED. THE AUDIBLE CUES OF THE MACHINE INDICATED THAT IT WAS FUNCTIONING PROPERLY, BUT VISUALLY I WAS NOT HAPPY WITH APPEARANCE CONCERNED THAT THERE WAS NO CAUTERY. WE RECHECKED GROUNDING PAD AND ALL CONNECTIONS. I ATTEMPTED AGAIN TO CONDITION, WITH NO AUDIBLE ALARMS, INDICATING 'NL FUNCTION'. AT THIS POINT A GREEN ERROR MESSAGE CAME UP BUT THE AUDIBLE CUES CEASED INDICATING NO CURRENT. THIS REPEATED ITSELF TWICE. I RECHECKED THE CONNECTIONS AND CHECKED TO AN ENDOCUT MODE (SOFT COAG FOLLOWED BY BURST OF CUTTING CURRENT). THE AUDIBLE CUES INDICATED PROPER FUNCTION AND I ASKED THE RN TO SLOWLY CLOSE THE SNARE. THE SNARE CLOSED AND A PIECE OF THE POLYP CAME OFF WITH NO CAUTERY SIGNS. THIS WAS FOLLOWED BY BRISK ARTERIAL BLEEDING WHICH I CONTROLLED ONLY AFTER GETTING A GOOD VISUAL FIELD BY REMOVING THE REMAINDER OF THE POLYP IN MULTIPLE PIECES USING A DIFFERENT CAUTERY DEVICE (CONMED BEAMER), WHICH FUNCTIONED PERFECTLY. I LEFT A PHOTODOCUMENTED COMPLETELY DRY FIELD AND ADMITTED THE PT FOR OBSERVATION, ON MONITOR. SHE REBLEED AND GOT VAGAL ON FLOOR. WAS TX TO ICU AND HAD NEG ANGIO. CURRENTLY 30 HRS, STABLE, NO TX. AND NO RE-BLED. HGB DROP FROM 13 TO 10."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 300 D ELECTROSURGICAL GENERATOR GEI ERBE ELECTROMEDIZIN GMBH VIO 300 D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization