BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1832588 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05235
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Report Date
    August 18, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PACKAGING WAS NOT RETURNED FOR EVALUATION THE PACKAGE WAS NOT RETURNED TO US FOR EVALUATION. ONLY THE DEVICE WAS RETURNED. WITHOUT THE PACKAGE TO EXAMINE, IT CANNOT BE DETERMINED WHAT OCCURRED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED THE DEVICE WITH THE STERILE PACKAGE OPEN. IT WAS NOT USED AND WILL BE RETURNED.

    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 G4T404

    Patients

    Seq Age Sex Outcome Treatment
    1