BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP EXTRA TITANIUM CLIPS

    MDR report key: 2770631 · Received October 3, 2012

    Report

    Report Number
    3005075853-2012-04515
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ANALYSIS RESULTS OF THE CARTRIDGE FOUND THAT IT WAS RECEIVED WITH THE COVER SLIGHTLY SEPARATED FROM THE BASE AND WITH TWO CLIPS LOADED. THE LATCHING FEATURE WAS EVALUATED AND THE ONE COVER TAB WAS NOTED TO BE DAMAGED LEADING TO THE FOUND CONDITION OF THE CARTRIDGE. IN ORDER TO AVOID THIS KIND OF ISSUE, IT IS RECOMMENDED TO INSERT THE CLIP CARTRIDGE INTO THE LOADING BASE. GRASP THE APPLIER IN THE BOX LOCK AREA USING PENCIL GRIP TECHNIQUE. INSERT THE JAWS OF THE INSTRUMENT INTO THE INDIVIDUAL CARTRIDGE SLOT, MAKING SURE THE TIPS OF THE APPLIER ARE PERPENDICULAR TO THE SURFACE OF THE CARTRIDGE. INSERT THE APPLIER UNTIL IT STOPS. DO NOT FORCE THE APPLIER. IT SHOULD ENTER AND WITHDRAW FROM THE CARTRIDGE SMOOTHLY. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED CARTRIDGE ISSUES. 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 AN OPEN LOBECTOMY PROCEDURE, THE CLIP DROPPED FROM THE JAWS JUST AFTER FEEDING AND WAS MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP EXTRA TITANIUM CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AL4P

    Patients

    Seq Age Sex Outcome Treatment
    1