BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 25MM CURVED

    MDR report key: 3896874 · Received June 26, 2014

    Report

    Report Number
    3005075853-2014-04429
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LOW ANTERIOR RESECTION PROCEDURE, THE CASE STARTED LAPAROSCOPIC AND THEN PFANNENSTIEL INCISION IN ORDER TO USE DEVICE LEAKED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374359 ILS 25MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CM48

    Patients

    Seq Age Sex Outcome Treatment
    1