BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3231780 · Received July 17, 2013

    Report

    Report Number
    3005075853-2013-03593
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 11, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, IN A DISCUSSION ON CLIP APPLIERS, THE SURGEON MENTIONED HE HAS BEEN HAVING ISSUES WITH THE CLIP APPLIERS. WHEN ADVANCING THE CLIP INTO THE JAWS, HE FEELS IT IS MORE DIFFICULT TO SQUEEZE THE TRIGGER. THEN WHEN HE HAS PLACED THE APPLIER AROUND THE STRUCTURE TO BE LIGATED, HE WILL TURN THE APPLIER SIDE TO SIDE TO CHECK THAT NOTHING UNINTENTIONAL IS WITHIN THE JAWS. HE SAYS THAT'S THE CLIP FALLS OUT ROUTINELY. IT DOES NOT SCISSOR, BUT MANY CLIPS FALL OUT OF THE JAWS. CASE COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331218 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1