BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO PATH ILS

    MDR report key: 2864977 · Received July 16, 2010

    Report

    Report Number
    2864977
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    May 27, 2010
    Report Date
    July 13, 2010
    Manufacturer
    JOHNSON & JOHNSON HEALTH CARE
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF INCREASED ABDOMINAL PAIN. THE PT HAD PREVIOUS SURGERY THAT WAS COMPLICATED BY A PELVIC ABSCESS. HE WAS TREATED WITH ANTIBIOTICS AND A PERCUTANEOUS DRAINAGE OF THE ABSCESS. THE PT DID NOT IMPROVE WITH CONSERVATIVE TREATMENT AND WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2010, FOR AN EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION AND SIGMOID COLON RESECTION. DURING THE ANASTOMOSIS FORMATION AT THE SIGMOID COLON SITE, THE ILS 33 STAPLER MALFUNCTIONED CAUSING ADD'L DAMAGE TO THE SIGMOID COLON. ATTEMPTS TO REPAIR THE DAMAGED PORTION WERE UNSUCCESSFUL AND A COLOSTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH ILS STAPLER ILS 33MM GDW JOHNSON & JOHNSON HEALTH CARE ECS33 G4RP9K

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability