BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2111050 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02237
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAWS. ADDITIONAL INFORMATION WAS REQUESTED. THE DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION MAKING THE DEVICE NON-FUNCTIONAL AND EMPTY. POSSIBLE CAUSES FOR THE CONDITION FOUND 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. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE, AFTER THE SURGEON INTRODUCED THE DEVICE DOWN THE TROCAR AND INTO THE ABDOMEN FOR THE FIRST FIRING THE DEVICE BEGAN TO EJECT THE CLIPS AND FORM MALFORMED CLIPS. THEY REMOVED THE CLIPS WITH A GRASPER. WHEN THE SURGEON FIRED THE CLIPS OUTSIDE OF THE PATIENT THE DEVICE FIRED FORMED CLIPS AND DID NOT EJECT THEM OUT OF THE APPLIER. THEY THEN USED A SECOND DEVICE THAT WAS WORKING PROPERLY BUT DUE TO THE BLEEDING IN THE PATIENT'S ABDOMINAL AREA THE SURGEON CONVERTED TO AN OPEN PROCEDURE. THEY USED SUTURE TO CONTROL THE BLEEDING AND COMPLETED THE PROCEDURE. NO KNOWN LOSS OF BLOOD WAS REPORTED AND AT THIS TIME, IT IS NOT KNOWN IF BLOOD PRODUCTS WERE GIVEN TO THE PATIENT. PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1