BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 2991395 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01089
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE. IT WAS SUTURED BY HAND TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95553 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1