BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*EXTRA TITANIUM CLIPS

    MDR report key: 1831623 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05209
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT, WHILE THE SURGEON WAS BUSY HARVESTING THE IMA WITHIN THE CHEST CAVITY, THE CLIP CLOSED INCORRECTLY AND TORE THE VESSEL THAT IT WAS TRYING TO SEAL. FORTUNATELY, THE SURGEON STILL HAD A STUMP OF THE VESSEL AVAILABLE TO SEAL, AND WAS ABLE TO USE ANOTHER APPLIER WITH ANOTHER CLIP TO SEAL THE VESSEL. THE CUSTOMER DISPOSED OF THE DEVICE; NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*EXTRA TITANIUM CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE