BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX

    MDR report key: 3023752 · Received March 27, 2013

    Report

    Report Number
    3005075853-2013-01416
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 AFTER A LAPAROSCOPIC GASTRIC BYPASS THE PATIENT HAD EXCESSIVE INTERNAL BLEEDING FROM A STAPLE LINE. THE PATIENT HAD TO BE RE-OPERATED ON 36 HOURS POST OPERATION TO OVERSEW THE BLEEDING STAPLE LINE. THE AREA IN QUESTION WAS THE REMAINING STOMACH (NOT THE POUCH). SURGEON USED A ENDOCUTTER WITH GOLD WITH PERI STRIPS ON GASTRIC FIRINGS. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126092 PWRD ECH FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ECR60D