BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ETS45

    MDR report key: 1994010 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00672
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THERE WAS BLEEDING FROM THE STAPLE LINE, WHICH REQUIRED A RE-OPERATION OF THE PATIENT IN ORDER TO REPAIR THE BLEEDING SITE. THEY USED THE SAME PRODUCT THE WHOLE OPERATION. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention