BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2001740 · Received February 25, 2011

    Report

    Report Number
    3005075853-2011-00758
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 02/25/2011. INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. THE FOLLOWING INFORMATION WAS REQUESTED: (B)(6). AFTER NUMEROUS ATTEMPTS TO OBTAIN THE ADDITIONAL INFORMATION, THE ACCOUNT ADVISED THAT THE SURGEON DOES NOT WISH TO ADD ANY FURTHER INFORMATION/COMMENTS REGARDING THIS PRODUCT COMPLAINT. THE ANALYSIS RESULTS FOUND THAT THE 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 CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON APPLIED CLIPS TO THE CYSTIC ARTERY AND CUT THE VESSEL; THE CLIPS THEN FELL OFF THE VESSEL AND CAUSED BLEEDING. THE SURGEON TRIED TO REAPPLY CLIPS BUT THE SAME THING HAPPENED AND THEY DID NOT HAVE ADEQUATE GRIP ON THE VESSEL. ON CLOSER INSPECTION OF THE CLIPS, THE DISTAL END HAD NOT FULLY COLLAPSED AND THERE WAS A GAP. THE PATIENT HAD TO BE CONVERTED TO AN OPEN PROCEDURE AS THE SURGEON WAS UNABLE TO CARRY ON LAPAROSCOPICALLY DUE TO BLEEDING. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4UC9L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention