BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

    MDR report key: 1831768 · Received January 15, 2008

    Report

    Report Number
    1527736-2008-00277
    Event Type
    Malfunction
    Date Received
    January 15, 2008
    Date of Event
    October 11, 2007
    Report Date
    October 17, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. NO FOREIGN MATTER WAS FOUND WHILE FIRING THE INSTRUMENT. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THERE WAS FOREIGN MATTER THAT APPEARED FROM THE DEVICE AFTER FIRING AT THE CONDITION OF NO CLIP INSIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HX5A

    Patients

    Seq Age Sex Outcome Treatment
    1