BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR SKIN STAPLER

    MDR report key: 4189856 · Received October 14, 2014

    Report

    Report Number
    MW5038672
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 14, 2014
    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

    THE DOCTOR STARTED USING THE INSORB SKIN CLOSURE ON THE PATIENT AND THE STAPLER DIDN'T PRESENT ANY STAPLES BELOW THE SKIN. ANOTHER DEVICE WAS PULLED AND WORKED. HAD ANOTHER INSORB SKIN CLOSURE FAIL A WEEK PRIOR BUT NO PATIENT INFORMATION WAS FORTH COMING. SAME LOT NUMBER ETC. BOTH DEVICES DID NOT CAUSE A DELAY OR HARM TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648731 INSORB SUBCUTICULAR SKIN STAPLER STAPLER GAG INCISIVE SURGICAL, INC. 2030 141701
    648732 INSORB SUBCUTICULAR SKIN STAPLER STAPLER GAG INCISIVE SURGICAL, INC. 2030 141701

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR