BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1782046 · Received January 24, 2008

    Report

    Report Number
    1527736-2008-00479
    Event Type
    Malfunction
    Date Received
    January 24, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 13, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: EMPTY INSTRUMENT, LOCKOUT BROKEN. EVALUATION SUMMARY: THE ER420 INSTRUMENT (A) WAS RETURNED EMPTY AND WITH THE LOCKOUT MECHANISM FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. NO CLIP FORMATION TESTING COULD BE PERFORMED AS THE INSTRUMENT WAS RETURNED EMPTY. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (B) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY PROCEDURE THE CLIP WAS NOT RELOADED IN THE RIGHT POSITION BETWEEN THE JAWS. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HH9A

    Patients

    Seq Age Sex Outcome Treatment
    1