BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 3914165 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04661
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THERE ANY BLEEDING THAT OCCURRED WHEN JAWS OF DEVICE CUT VESSEL? IF BLEEDING, PLEASE QUANTIFY AMOUNT OF BLEEDING? WAS PATIENT GIVEN ANY BLOOD PRODUCTS? WAS THERE ANY CHANGE TO PROCEDURE OR POST OP PATIENT CARE? HOW WAS VESSEL REPAIRED? DID NEW MSM20 WORK TO CONTROL THE BLEEDING DURING PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AT THE FIRST ACTIVATION, THE CLIP WOULD NOT ADVANCE, THE VESSEL WAS CUT. WAITING FOR MORE INFORMATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391906 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA L4E73R

    Patients

    Seq Age Sex Outcome Treatment
    1