BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED LONG APPLIER

    MDR report key: 6324076 · Received February 10, 2017

    Report

    Report Number
    3005075853-2017-00872
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 6, 2017
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN CARDIOVASCULAR SURGERY, THE CLIP WAS MALFORMED IN W-SHAPE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105286 LIGACLIP MCA MED LONG APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1