BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3140448 · Received May 31, 2013

    Report

    Report Number
    3005075853-2013-02710
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 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). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION:MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP WAS NOT DEPLOYED PROPERLY WHEN THE DEVICE WAS USED ON THE CHOLECYST. THE CLIP FELL OUT FROM THE JAWS AND THE DEVICE COULD NOT BE USED. 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
    241995 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1