BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3913928 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04653
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 16, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS OF THE ER320 DEVICE FOUND THAT IT WAS RECEIVED FOR ANALYSIS. THE RETURNED DEVICE WAS NOTED TO HAVE THE JAWS MISALIGNED AND YIELDED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE CLIPS WERE FED AS INTENDED; HOWEVER, DUE TO THE MISALIGNED CONDITION OF THE JAWS 13 SCISSORED CLIPS WERE FORMED. 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 IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE YIELDED CONDITION OF THE JAWS MAY LEAD DROPPING/EJECTED CLIPS. IN ADDITION THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE LOCKOUT POSTS WERE FOUND TO BE BROKEN WHICH SUGGEST THAT A LOCKOUT PREMATURE OCCURRED AND LEADING THE INCIDENT REPORTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FOUND THE FINDING. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS FIRED FROM THE DEVICE DID NOT FULLY CLOSE AFTER THE FIRST FIRING. IT APPEARED AS THOUGH THE DISTAL END CLOSED, BUT THE PROXIMAL REMAINED OPEN. THE DEVICE WAS PULLED AND FIRED OUTSIDE OF THE PATIENT WITHOUT ISSUE. CASE COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389603 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1