BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5 MM - STANDARD

    MDR report key: 1053146 · Received May 16, 2008

    Report

    Report Number
    1527736-2008-03082
    Event Type
    Injury
    Date Received
    May 16, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. THE PATIENT WAS IN THE PACU, WHEN IT WAS NEEDED TO RETURN THEM TO THE OR TO PLACE CLIPS FOR BLEEDING. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5 MM - STANDARD GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention