BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP**

    MDR report key: 3613632 · Received February 7, 2014

    Report

    Report Number
    3005075853-2014-00918
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WHAT IS MEANT BY "CLIP DID NOT LOAD INTO THE JAWS CORRECTLY" PLEASE PROVIDE MORE DETAIL REGARDING ISSUE SUCH AS CLIP FED SIDEWAYS, CLIP FED SLOWLY, MULTIPLE CLIPS FED, OR NO CLIPS FED INTO JAWS AT ALL. YES THE CLIP FED SLOWLY INTO THE JAWS AND THEN ONCE RELEASING THE TRIGGER THE CLIP TURNED SIDEWAYS AND WAS POSITIONED ABOUT 45DEGREES INCORRECTLY ACROSS THE JAWS. THE CLIP WAS WEDGED AWKWARDLY BETWEEN THE JAWS AND NEEDED TO BE REMOVED MANUALLY. SECOND CLIP FIRED HAD THE SAME PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL COLECTOMY PROCEDURE, THE SCRUB NURSE FIRED ONE CLIP TO ENSURE WORKING CORRECTLY, IT FIRED SIDEWAYS OUT OF JAWS. I ASKED TO FIRE A SECOND AND AGAIN THE CLIP DID NOT LOAD INTO THE JAWS CORRECTLY. A SECOND DEVICE WAS OPENED. ON THIS OCCASION THE FIRST CLIP LOADED AND FORMED CORRECTLY. HANDED TO SURGEON, WHO FIRED A COUPLE AND ALL DID NOT LOAD OR FORM CORRECTLY. THE OPEN CLIPS REMOVED FROM THE PATIENT AND A HEM-O-LOCK CLIP APPLIER WAS USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79354 LIGACLIP** CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1