BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR SKIN STAPLER

    MDR report key: 2916263 · Received January 9, 2013

    Report

    Report Number
    MW5028560
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 3, 2013
    Manufacturer
    INCISIVE SURGICAL INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE STAPLER DID NOT PULL SKIN TOGETHER; LEFT A GAP. NEW STAPLER REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11773 INSORB SUBCUTICULAR SKIN STAPLER ABSORBABLE STAPLES GDW INCISIVE SURGICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR