BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1463902 · Received June 19, 2009

    Report

    Report Number
    3005075853-2009-03668
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    May 4, 2009
    Report Date
    May 4, 2009
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/19/2009. ADVANCER BYPASS, MALFORMED CLIP. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED 8 CLIP CONFORMING AND 1 MALFORMED CLIP DUE TO BYPASS ISSUES. IN ADDITION THE ORANGE INDICATOR DID NOT SHOWED UP AFTER THE DEVICE LOCKED OUT. 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. 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WOULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA F4NF7W

    Patients

    Seq Age Sex Outcome Treatment
    1