BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 271826 · Received March 31, 2000

    Report

    Report Number
    271826
    Event Type
    Injury
    Date Received
    March 31, 2000
    Date of Event
    February 11, 2000
    Report Date
    March 10, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPY THERE WAS A MALFUNCTION OF THE 10/11 MM UMBILICAL TROCAR WHICH RESULTED IN A VESSEL INJURY. THE SLEEVE DID NOT RETRACT OVER THE BLADES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ENDOPATH 511SD 11MM GCJ ETHICON ENDO-SURGERY, INC. 511SD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R