BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 PROXIMATE

    MDR report key: 325976 · Received April 6, 2001

    Report

    Report Number
    MW1021571
    Event Type
    Injury
    Date Received
    April 6, 2001
    Date of Event
    March 24, 2001
    Report Date
    April 5, 2001
    Manufacturer
    ETHICON-ENCO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO MAIN OR TO UNDERGO EXPLORATORY LAPAROTOMY RECTOSIGMOIDECTOMY, HARTMANN'S POUCH AND COLOSTOMY, INTRAOPERATIVE FINDINGS DEMONSTRATED A PROXIMAL RECTUM THAT WAS PERFORATED LATERALLY SECONDARY TO A DISTAL RECTAL OBSTRUCTING MASS. DURING TRANSECTION OF THE DISTAL RECTUM, THE STAPLER MALFUNCTIONED AND THE RECTAL STUMP WAS OVERSEWN USING SILK SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15154 1 PROXIMATE ACCESS 55 ARTICULATING LINEAR STAPLER GAG ETHICON-ENCO-SURGERY, INC. AX55G N4JU00

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention