BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MED APPLIER

    MDR report key: 1081074 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00577
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE PRODUCED BENT AND MALFORMED CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA MED APPLIER GDO ETHICON ENDO-SURGERY, LLC NA E4KV03

    Patients

    Seq Age Sex Outcome Treatment
    1