BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 2990154 · Received February 6, 2013

    Report

    Report Number
    3004028675-2013-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 7, 2013
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH OR SERIOUS INJURY IS NOT LIKELY WITH RECURRENCE OF THIS REPORTED PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED STAPLER LEFT A GAP, NEW STAPLER REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50311 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDW INCISIVE SURGICAL 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR