BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA SMALL APPLIER

    MDR report key: 2221451 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03474
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS BEING USED FOR AN INTERNAL MAMMARY TAKEDOWN WHEN THE SURGEON NOTED THE APPLIER SEEMED TO BE SCISSORING BEFORE THE TRIGGER WAS ENGAGED. THE ISSUE WAS NOTICED PRIOR TO USE ON THE PATIENT. DEVICE WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER CLIP APPLIER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H4398R

    Patients

    Seq Age Sex Outcome Treatment
    1