BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1463904 · Received June 19, 2009

    Report

    Report Number
    3005075853-2009-03666
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    January 21, 2009
    Report Date
    January 23, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). ADVANCER BYPASS, MALFORMED CLIP. EVAL SUMMARY: THE DEVICE WAS RECEIVED IN GOOD CONDITION. IT WAS CYCLED, FED AND FORMED TWO CONFORMING CLIPS AND THEN AN ADVANCER BYPASS ISSUE WAS NOTED. THE JAWS REMAINED IN CLOSED POSITION AND THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; ONE PEAR SHAPED CLIP WAS RELEASED. AT THE END, THE DEVICE LOCKED OUT AS INTENDED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. 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 FIRED A COUPLE CLIPS AND THEN JAMMED. THE CASE WAS COMPLETED BY AN UNKNOWN MEANS. 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 E4LM95

    Patients

    Seq Age Sex Outcome Treatment
    1