BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1834599 · Received September 15, 2010

    Report

    Report Number
    3005075853-2010-05267
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS RECEIVED ON (B)(4) 2010:(B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED WITH A CLIP WITH GAP ATTACHED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6), 2010 AN INCIDENT WHERE THE MIDDLE INJECTION PORT LEAKED AFTER COMPOUNDING WITH THIS ALL-IN-ONE EMPTY CONTAINER. THIS INCIDENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON CLAIMS THAT THE CLIPS ARE NOT FORMING CORRECTLY. HE CLAIMS THAT SOME OF THE CLIPS ARE NOT FULLY CLOSING AND THAT OTHERS WERE CLOSING AT THE DISTAL END BUT NOT FULLY AT THE PROXIMAL END. HE HAD TO USE A MARYLAND TO FULLY CLOSE THE CLIP. WHEN THE SALES REP SPOKE WITH THE SURGEON, HE WAS ASKED IF IT WAS POSSIBLE THAT HE HAD CLOSED THE CLIP APPLIER ON A HARD/METAL OBJECT- HE SAID NO AND THAT HE NOTICED THAT THE CLIPS WEREN'T FORMING FROM THE VERY FIRST ONE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TC4E

    Patients

    Seq Age Sex Outcome Treatment
    1