BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO PATH ILS

    MDR report key: 260650 · Received February 1, 2000

    Report

    Report Number
    260650
    Event Type
    Injury
    Date Received
    February 1, 2000
    Date of Event
    January 14, 2000
    Report Date
    January 27, 2000
    Manufacturer
    ETHICION ENDO SURGERY, INC
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE EEA STAPLER FROM RECTUM A TEAR OCCURRED IN THE BOWEL. EEA FAILED CAUSING HOLES IN THE BOWEL. STAPLES DID NOT FORM CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO PATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER GAG ETHICION ENDO SURGERY, INC ECS33 M4EC4J

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R