BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2990931 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01060
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 21, 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
    PA, 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, SOME OF THE CLIPS WOULD SCISSOR IN THE JAWS OF THE DEVICE, SOME OF THE CLIPS WILL ALSO SCISSOR WHEN APPLIED TO THE VESSEL, AND SOME OF THE CLIPS WILL FALL OFF OF THE VESSEL AFTER THEY ARE APPLIED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. THIS IS ALL THE INFORMATION AVAILABLE. NO DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96140 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1