BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2043341 · Received April 7, 2011

    Report

    Report Number
    1527736-2011-00088
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.ADDITIONAL INFORMATION HAS BEEN REQUESTED, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF FURTHER DETAIL.

    Description of Event or Problem · 1

    PT . IS OK. WE DON'T HAVE ANY FURTHER INFO ABOUT WHERE ON STAPLE LINE LEAK WAS NOTED. THIS SURGEON HAS BEEN USING THE DEVICE OVER A YR AND WAITS 15 SECONDS AND USES IT WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PATIENT WAS BROUGHT BACK TWO DAYS POST OP DUE TO A LEAK HOWEVER THE PATIENT'S SYMPTOMS ARE UNKNOWN. THE LEAKS WERE REPAIRED USING SUTURE. THERE WAS FOUND TO BE TWO DIFFERENT LEAKS ON THE STAPLE LINE. ONE LEAK WAS AT THE TOP WHERE THE WHITE LOAD ON THE JEJUNOJEJUNOSTOMY AND THE SECOND LEAK WAS AT THE GASTROTOMY SITE. THE PATIENT IS CURRENTLY DISCHARGED AND DOING OKAY. THE DETAILS ON HOW THE DEVICE FIRED ON THE ORIGINAL CASE IS UNKNOWN. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention