BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH

    MDR report key: 537412 · Received July 28, 2004

    Report

    Report Number
    537412
    Event Type
    Injury
    Date Received
    July 28, 2004
    Date of Event
    July 2, 2004
    Report Date
    July 8, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FHP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY, UPON INSERTING VERRES NEEDLE THE SMALL BOWEL WAS PUNCTURED, NECESSITATING ADD'L SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH VERRES NEEDLE FHP ETHICON ENDO-SURGERY, INC. PN150 2008-07

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention