BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM

    MDR report key: 1122024 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01210
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 31, 2008
    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

    DATE SENT: 08/14/2008. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP BYPASS PROCEDURE, THE DEVICE WAS PRE LOADED BY THE SCRUB NURSE AND THEN PASSED TO THE SURGEON. HE CLIPPED A VESSEL AND THE CLIPS WERE FINE. HE THEN CAME TO TAKE THE NEXT VESSEL AND THE APPLIER FIRED AS NORMAL. BUT THE CLIP REMAINED IN THE JAWS OF THE APPLIER. ANOTHER CLIP WAS THEN FIRED AND THIS CAME OUT OF THE JAWS BUT WOULD NOT REMAIN ON THE VESSEL. IT WOULD NOT CLOSE PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 20 MEDIUM FZP ETHICON ENDO-SURGERY, LLC NA E4KY65

    Patients

    Seq Age Sex Outcome Treatment
    1