BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2875369 · Received December 17, 2012

    Report

    Report Number
    3005075853-2012-05767
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 7, 2012
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED. THE DEVICE WAS TEST-LOADED BY THE SCRUB NURSE BEFORE PASSING IT TO THE SURGEON. INSTEAD OF LOADING PROPERLY, THE CLIP WAS EJECTED FROM THE CLIP APPLIER. THE DEVICE WAS THEREFORE SET ASIDE AND ANOTHER ONE WAS OPENED TO CARRY OUT THE SURGERY, WHICH WAS A LAPAROSCOPIC CHOLECYSTECTOMY. DID THE CLIPS HOLD ON THE VESSEL AFTER BEING APPLIED? N/A. DID THE CLIP FALL INTO THE PATIENT? NO. IF YES, HOW WAS THE CLIP RETRIEVED? N/A. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? N/A. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? THE PROBLEM OCCURRED WHEN TRYING TO LOAD THE FIRST CLIP. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT WAS FOUND? LAPAROSCOPIC CHOLECYSTECTOMY. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? YES. SCRUB NURSE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AN UNKNOWN SURGERY, THE CLIP APPLIER FAILED TO APPLY PROPERLY CLOSE CLIPS. NO OTHER INFORMATION IS AVAILABLE AT THE MOMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4UD09

    Patients

    Seq Age Sex Outcome Treatment
    1