BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM

    MDR report key: 1003658 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00919
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 02/14/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE DROPPING CLIPS. THE CLIPS FELL FROM THE DEVICE (NOT INTO THE PATIENT) AND THE CLIPS WHICH COULD BE PLACED DID NOT HOLD. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM FZP ETHICON ENDO-SURGERY, INC. NA D4JP71

    Patients

    Seq Age Sex Outcome Treatment
    1