BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3173348 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03073
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 3, 2013
    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). THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING THE DEVICE FOR FUNCTIONALITY THE DEVICE WAS CYCLED, FED, AND FORMED TWO CLIPS AS INTENDED AND IT EJECTED FIFTEEN CLIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSECTOMY PROCEDURE, THE CLIP WAS NOT FED INTO THE JAWS PROPERLY AND THE CLIP FELL OUT FROM THE JAWS OUTSIDE OF THE PATIENT AT THE 2ND FIRING. THE CLIP DID NOT FALL INTO THE PATIENT. 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
    273826 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1