BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1834571 · Received September 15, 2010

    Report

    Report Number
    3005075853-2010-05266
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 25, 2010
    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
    EI
    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 AN UNKNOWN PROCEDURE, THE SURGEON CLAIMS THAT THE CLIPS ARE NOT FORMING CORRECTLY. SURGEON CLAIMS THAT SOME OF THE CLIPS ARE NOT FULLY CLOSING AND THAT OTHERS WERE CLOSING AT THE DISTAL END BUT NOT FULLY AT THE PROXIMAL END. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE; NO DEVICE WILL BE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1