BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 2900379 · Received January 7, 2013

    Report

    Report Number
    3005075853-2013-00110
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. 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. PLEASE CLARIFY WHAT IS MEANT BY ¿THE CLIPS CAME OUT CROSS¿? DESCRIBE THE SHAPE OF THE CLIP. WHICH FIRING DID THIS OCCUR ON? WHAT CAUSED THE INITIAL BLEEDING? DID THE PATIENT RECEIVE A BLOOD TRANSFUSION? PLEASE CONFIRM THE DEVICE WAS BEING FIRED ON THE CYSTIC ARTERY. HOW WAS THE PROCEDURE COMPLETED? WAS THE DEVICE FIRED ACROSS ANOTHER CLIP, STAPLE, OR HARD OBJECT? WAS THE CLIP FULLY ADVANCED IN THE JAWS OF THE DEVICE? DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? WERE ANY UNEXPECTED NOISES HEARD? DID ANYTHING HAPPEN UNEXPECTEDLY PRIOR TO THE EVENT? WAS THE PATIENT'S POST OPERATIVE CARE ALTERED? IF SO, PLEASE EXPLAIN. WHAT IS THE PATIENT'S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? PATIENT'S SEX, AGE, AND WEIGHT? THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TIPS OF THE JAW SLIGHTLY MISALIGNED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED AND FORMED ONE SCISSORED CLIP. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT AN INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON WAS GOING TO CLIP THE BLEEDING ARTERY WHEN THE CLIPS CAME OUT CROSS. THE PATIENT WAS CONVERTED TO OPEN BECAUSE THE BLEEDING WAS NOT ABLE TO BE STOPPED. THE PATIENT IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6346 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CLOP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention