BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 1844244 · Received September 24, 2010

    Report

    Report Number
    3005075853-2010-05495
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JUST TO CLARIFY, THE CONVERSION WAS DUE TO THE LACK OF CYSTIC ARTERY REMAINING AFTER THE INADEQUATE CLIP FORMATION? YES. HOW DID DR (B)(6) COMPLETE THE CASE ONCE HE CONVERTED TO OPEN? TIED. WAS THE PATIENT'S POST OPERATIVE CARE ALTERED DUE TO THE CONVERSION? YES, PATIENT WAS ADMITTED AND WOULD NORMALLY HAVE GONE HOME. WHAT IS THE PATIENT'S CURRENT STATUS? FINE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENT'S SEX, AGE, WEIGHT? ANY PRE-EXISTING CONDITIONS? (B)(6) MALE.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS FIRED ON THE CYSTIC ARTERY. WHEN THE SURGEON ANGLED THE CAMERA TO VIEW THE CLIP PLACEMENT THE CLIPS WERE LOOSELY FORMED ON THE TISSUE, PEAR SHAPED AND DID NOT CLOSE ALL THE WAY. AN ENDOLOOP WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR