BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 2954190 · Received February 11, 2013

    Report

    Report Number
    3005075853-2013-00564
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 18, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CUSTOMER REPORTED THAT THE CLIP DID NOT FORM CORRECTLY. THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58243 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CE05

    Patients

    Seq Age Sex Outcome Treatment
    1