BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3892406 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04337
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLIP JAMMED, MALFORMED CLIP. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A MALFORMED CLIP JAMMED IN JAWS AND FED SIDEWAYS; THIS CONDITION PREVENTED THE DEVICE FROM PROPER FEEDING OF THE CLIPS. THE JAWS WERE NOTED TO BE PROPERLY ALIGNED. THE JAMMED CLIP WAS REMOVED FROM THE JAWS AND IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, RETAINED AND FORMED THE REMAINING 7 CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RETURNED CONDITION OF THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP WAS FED INTO THE JAWS SIDEWAYS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368003 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1