BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1443796 · Received June 4, 2009

    Report

    Report Number
    3005075853-2009-03335
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    April 20, 2009
    Report Date
    April 20, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/04/2009. BROKEN JAW. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED WITH THE JAWS BROKEN. THE MOST LIKELY REASON FOR THE JAW BREAKAGE IS STRESS CORROSION CRACKING AND THE MOST LIKELY ROOT CAUSE IS EXPOSURE TO A SOLUTION CONTAINING CHLORINE. THIS TYPE OF BREAKAGE IS VERY UNLIKELY TO OCCUR DURING A SURGICAL PROCEDURE AND IS MOST LIKELY TO OCCUR AFTER POST-SURGERY DEVICE CLEANING. THE JAW BREAKAGE IS NOT OCCURRING AS A RESULT OF THE PRODUCT COMPLAINT DECONTAMINATION PROCESS. THE INSTRUMENT WAS CYCLED AND IT EJECTED ELEVEN CLIPS DUE TO THE FOUND CONDITION; NO JAMMING ISSUES WERE NOTED. 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 DID NOT CLIP ON THE SECOND FIRING. ON THE THIRD FIRING THE DEVICE JAMMED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA F4NE4F

    Patients

    Seq Age Sex Outcome Treatment
    1