BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1781987 · Received January 30, 2008

    Report

    Report Number
    1527736-2008-00574
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Report Date
    November 29, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DAMAGED CARTRIDGE COVER. EVALUATION SUMMARY: THE INSTRUMENT WAS RETURNED WITH THE CARTRIDGE COVER CRACKED. THE INSTRUMENT WAS CYCLED AND EJECTED AND REMAINING CLIPS DUE TO THE CARTRIDGE COVER CONDITION. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CARTRIDGE COVER CONDITION NOR THE REPORTED EVENT. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE LOCKED OUT. THEY GOT A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER GDO ETHICON ENDO-SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1