BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 3954896 · Received July 24, 2014

    Report

    Report Number
    3005075853-2014-05184
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 16, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE BLEEDING MENTIONED A MEASURABLE AMOUNT AND IF SO HOW MANY CC'S? DID THE PATIENT REQUIRE BLOOD PRODUCTS AND IF SO HOW MANY UNITS?DID THE DEVICE DELIVER A SCISSORED CLIP WHICH CUT THE STRUCTURE? DID THE DEVICE DELIVER A PROPERLY FORMED CLIP WHICH CUT THE STRUCTURE? DID THE CLIP NOT FEED INTO THE JAWS, RESULTING IN THE JAWS CUTTING THE STRUCTURE UPON FIRING? (IF YES, PLEASE REFERENCE THE IFU WHICH STATES TO ENSURE VISUALIZATION OF THE CLIP IN THE JAWS PRIOR TO FIRING.) HOW WAS THE STRUCTURE REPAIRED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLASTIC SURGERY PROCEDURE, THE CLIP APPLIER WAS USED AND CUT THE VESSEL RATHER THAN LIGATING CAUSING THE SURGEON TO STEM THE BLEEDING CAUSED. DEVICE WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433749 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1