BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP EXTRA TITANIUM

    MDR report key: 2082420 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01890
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 13, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (A) FOUND THAT IT WAS RECEIVED WITH THE COVER SEPARATED FROM THE BASE AND EMPTY. THE LATCHING FEATURE WAS EVALUATED AND THE ONE COVER TAB WAS NOTED TO BE DAMAGED LEADING 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. THE ANALYSIS RESULTS OF CARTRIDGE (B) FOUND THAT IT WAS RECEIVED WITH THREE PREFORMED CLIPS INSIDE THE CARTRIDGE. UPON FUNCTIONAL TESTING OF THE DEVICE, ONLY TWO CLIPS WERE LOADED, RETAINED AND FORMED AS INTENDED. AS THE LAST CLIP WAS NOT PROPERLY LOADED INTO THE CARTRIDGE POCKET, IT COULD NOT BE LOADED TO THE CLIP APPLIER. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (C) FOUND THAT IT WAS RECEIVED WITH THE COVER SEPARATED FROM THE BASE AND WITH TWO PREFORMED CLIPS LOADED. THE LATCHING FEATURE WAS EVALUATED AND THE ONE COVER TAB WAS NOTED TO BE DAMAGED LEADING 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. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (D) FOUND THAT IT WAS RECEIVED EMPTY. THE CARTRIDGE WAS NOTED CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (E) FOUND THAT IT WAS RECEIVED EMPTY. THE CARTRIDGE WAS NOTED CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (F) FOUND THAT IT WAS RECEIVED WITH ONE PREFORMED CLIP INSIDE THE CARTRIDGE. UPON FUNCTIONAL TESTING OF THE DEVICE, THE CLIP WAS LOADED, RETAINED AND FORMED AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGE (G) FOUND THAT IT WAS RECEIVED WITH SIX PREFORMED CLIP INSIDE THE CARTRIDGE. UPON FUNCTIONAL TESTING OF THE DEVICE, THE CLIPS WERE LOADED, RETAINED AND FORMED AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE ANALYSIS RESULTS OF CARTRIDGES (H, I, J, K, AND L) FOUND THAT THEY WERE RECEIVED INSIDE THE ORIGINAL PACKAGES. UPON FUNCTIONAL TESTING OF THE CLIPS WERE LOADED, RETAINED AND FORMED AS INTENDED; NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WOULD NOT HOLD AFTER PLACING. THEY ARE NOT FIXED INTO THEIR PACKAGE/CARTRIDGE AND WERE THEREFORE DIFFICULT TO GRASP, DISLODGED THEMSELVES WHEN THE BOX WAS MOVED, ARE NOT CORRECTLY PLACED INTO THE APPLIER JAWS. THERE IS A RISK OF FALLING INTO THE PATIENT, AND VERY DIFFICULT HANDLING. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP EXTRA TITANIUM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4347H

    Patients

    Seq Age Sex Outcome Treatment
    1