BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1121925 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01173
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/13/2008. THE ANALYSIS RESULTS FOR THE EL5ML DEVICE FOUND THAT IT WAS RETURNED WITH THE CAM BROKEN. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIP DUE TO THE CAM CONDITION. WE HAVE DOCUMENTED TO CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WORKED WELL, BUT IT ONLY CONTAINED 7 CLIPS. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA D4JY16

    Patients

    Seq Age Sex Outcome Treatment
    1