BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR SKIN STAPLER

    MDR report key: 6193329 · Received December 19, 2016

    Report

    Report Number
    MW5066822
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 19, 2016
    Manufacturer
    INCISIVE SURGICAL INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE SCRUB TECH THE INSORB STAPLER WAS WORKING ON ONE SIDE OF THE STAPLE GUN ONLY WHICH PREVENTED IT FROM DEPLOYING THE STAPLES CORRECTLY AS THE OTHER SIDE OF THE GUN WAS NOT WORKING. THE DEFECTIVE EQUIPMENT WAS CHANGED OUT TO ANOTHER STAPLER FOR THE REST OF THE C-SECTION CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836283 INSORB SUBCUTICULAR SKIN STAPLER STAPLER GAG INCISIVE SURGICAL INC. 162701

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR