BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 4852298 · Received June 17, 2015

    Report

    Report Number
    3005075853-2015-03683
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ER320 DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE EJECTED DUE TO THE CONDITION OF THE JAWS; NO SCISSORED CLIPS WERE FORMED. FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE YIELDED JAWS MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, WHEN TRYING TO PUT THE CLIPS ON THE VESSEL, SURGEON NOTICED THAT CLIPS ARE NOT FORMED PROPERLY. SOME OF THE CLIPS WERE IN SCISSOR SHAPE. A COMPETITOR¿S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. THERE WAS A DELAY OF FIFTEEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395534 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4HE6M

    Patients

    Seq Age Sex Outcome Treatment
    1