BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC CLIP APPLIER

    MDR report key: 3761127 · Received April 21, 2014

    Report

    Report Number
    3005075853-2014-02727
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 4, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING 6 CLIPS AS INTENDED. IN ORDER TO CONFIRM THE CLIPS WERE WITHIN MANUFACTURING SPECIFICATIONS, THE CLIPS WERE EVALUATED USING A TOOL THAT IS DESIGNED TO DETERMINE PROPER FORMATION. DURING ANALYSIS THE JAWS OPENED AND CLOSED AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THREE CLIPS WERE APPLIED TO THE DUCT AND WOULD NOT HOLD ONTO THE TISSUE. THE CLIPS SLIPPED OFF THE TISSUE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO CHOLANGIOGRAM WAS USED WITH THIS PROCEDURE. ALL AVAILABLE INFORMATION WAS REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241134 ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4DR7W

    Patients

    Seq Age Sex Outcome Treatment
    1