BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC APPLICATOR

    MDR report key: 6879020 · Received September 20, 2017

    Report

    Report Number
    9610614-2017-00026
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    September 4, 2017
    Report Date
    September 20, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K003462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INSPECTION OF THE APC APPLICATOR REVEALED MECHANICAL DAMAGE AND MELTING. THE APPLICATOR WAS BENT AND THE APPLICATOR'S IGNITION ELECTRODE WAS NO LONGER INSULATED. ALSO, SOME OF THE INSULATION WAS MELTED. THE APC HANDLE'S CUT AND SWITCHING BUTTONS WERE NOT WORKING BUT THE COAG BUTTON WORKED PROPERLY. THE HANDLE'S CONDITION WAS NOT ASSOCIATED WITH THE REPORTED EVENT. THE APC AND ESU WERE FOUND TO FUNCTIONING AS INTENDED AND WITHIN SPECIFICATIONS. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED EVENT. IT APPEARS THAT DURING THE PROCEDURE, THE APC APPLICATOR WAS BENT/DAMAGED. THE INSULATION WAS THEN NOT INTACT AND ELECTRICAL CURRENT FOLLOWED THE LEAST PATH OF RESISTANCE WHICH RESULTED IN THE UNINTENDED THERMAL DAMAGE TO THE PATIENT'S STOMACH WALL. IT SPECIFIES IN THE APPLICATOR'S NOTES ON USE AS WARNINGS NOT TO DAMAGE A INSTRUMENT AND NOT TO USE A DAMAGED INSTRUMENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT AN ARGON PLASMA COAGULATION (APC) APPLICATOR WAS INVOLVED IN A PATIENT INCIDENT. A LAPAROSCOPIC PROCEDURE WAS PERFORMED TO TREAT A POLYTRAUMA (NOTE: THE SPECIFICS OF THE PATIENT'S MEDICAL PROBLEMS WERE NOT REPORTED.). THE APC APPLICATOR WAS USED IN CONJUNCTION WITH AN ARGON PLASMA COAGULATOR [APC, MODEL APC 2, PART NUMBER (P/N) 10134-000, SERIAL NUMBER (S/N) (B)(4)], ELECTROSURGICAL UNIT (ESU, MODEL VIO 300 D, P/N 10140-000, S/N (B)(4)), AND AN APC HANDLE [P/N 20132-043, LOT NUMBER (L/N) WO190681]. AN ERBE NESSY OMEGA RETURN ELECTRODE (PART NUMBER 20193-082) WAS ALSO USED IN THE PROCEDURE. DURING THE USE OF THE APC APPLICATOR, AN ALTERNATE SITE BURN/NECROSIS OCCURRED AT THE SEROSA OF THE STOMACH WALL. THE NECROSIS WAS ROUND-SHAPED, 3 MM IN DIAMETER, WHITISH IN THE CENTER, AND BLACK AT THE MARGIN. THE DAMAGE TO THE TISSUE APPEARS TO HAVE BEEN THE RESULT OF A FLASHOVER FROM THE INSTRUMENT DUE TO A BREACH IN THE APPLICATOR'S INSULATION. NEVERTHELESS TO ADDRESS THE ISSUE, THE NECROTIC AREA ON THE SEROSA OF THE STOMACH WALL WAS SUTURED TO PREVENT A PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661072 ERBE APC APPLICATOR APC APPLICATOR GEI ERBE ELEKTROMEDIZIN GMBH WO180899

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other