BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AREPIN

    MDR report key: 270595 · Received March 15, 2000

    Report

    Report Number
    270595
    Event Type
    Injury
    Date Received
    March 15, 2000
    Date of Event
    January 11, 2000
    Report Date
    January 21, 2000
    Manufacturer
    CON MED ASPEN LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARGON PLASMA COAGULATOR ARGON BEAM COAGULATOR USED FOR REMOVAL (ABLATED) OF POLYPS AT CECUM (FLAT POLYP) RECOVER PERIOD COLOR ASHEN, HEART RATE DECREASED TO 33 BLOOD PRESSURE - 77/30 - COMPLAINED OF ABDOMINAL ABD CRAMPING - ABDOMEN DISTENDED AND TIGHT, ABDOMEN FILMS SHOWED FREE AIR, ACUTE SURGICAL ABDOMEN AND DIFFUSE PERITONITIS. URGENT LAPAROTOMY PERFORMED COLON RESECTION (RT. HEMISECTOMY) PATH 11.5 COLONIC SURGICAL MARGIN AREA OF PERFORATION 0.3 - 0.5 CM COLONIC MUCOSA DARK GREY TAN TO GREY BLACK 2.2 CM DIMENSION PERFORATION HAD ADJACENT TUBULAR ADENOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AREPIN AREPIN PLASMA COAGULATOR GEI CON MED ASPEN LAB 60-7500-120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization| R