BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3912822 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04635
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULT SHOWED THAT THE ER320 INSTRUMENT WAS RECEIVED EMPTY AND WITH THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION MAKING THE DEVICE NON-FUNCTIONAL. 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT 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. DUE TO THE CONDITION OF THE RETURNED DEVICE IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE MALFORMED. UNKNOWN AT WHAT FIRING. THEN THE CLIPS STARTED FALLING OUT OF THE DEVICE. IT IS UNKNOWN IF THEY FELL IN THE PATIENT. THE SURGEON WAS TORQUING THE DEVICE DURING FIRING. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390886 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1