BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 1871340 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05890
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    July 5, 2010
    Report Date
    September 21, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE ACCOUNT: THE SURGEON WAS UNABLE TO RELEASE THE JAWS (UNAWARE IF THE SURGEON KNOWS TO PULL THE HANDLES APART PER THE IFU) RESULTING IN THE TEARING OF THE DUCT. THE SURGEON REPAIRED THE DUCT LAPAROSCOPICALLY AND CLOSED THE PATIENT. DAYS LATER THE PATIENT PRESENTED WITH A LEAK AND WAS TAKEN BACK TO THE OPERATING ROOM. THE SURGEON OPENED THE PATIENT AND REPAIRED THE DUCT (THE LEAK WAS IN THE SAME AREA WHERE THE DUCT WAS TORE AND REPAIRED - UNKNOWN IF THE LEAK WAS DUE TO THE TEAR OR AN UNSUCCESSFUL REPAIR). THE PATIENT WAS SENT TO ICU AND APPROXIMATELY ONE WEEK LATER PRESENTED WITH AN ABSCESS INFECTION. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO ADDRESS THE INFECTION AND WAS THEN SENT TO RECOVERY. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT WAS RELEASED A FEW DAYS LATER. ADDITIONAL INFORMATION FROM THE SALES REPRESENTATIVE: "THE STAFF HAS BEEN IN-SERVICED AS WELL AS THE MAIN DOCS AT THE HOSPITAL." THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2010, THE JAWS OF THE DEVICE LOCKED AND WOULD NOT OPEN. THE SURGEON ATTEMPTED TO PULL THE DEVICE OFF AND THE CYSTIC DUCT WAS TORN. IT WAS REPAIRED LAPAROSCOPICALLY AND PROCEDURE COMPLETED. ON (B)(6) 2010 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND HAD TO BE OPENED IN ORDER TO REPAIR A LEAK FOUND IN THE CYSTIC DUCT. NO DETAILS OF HOW IT WAS REPAIRED. AS A RESULT OF THE TEAR, THE PATIENT DEVELOPED AN INFECTION, WAS INCUBATED AND HAD TO BE PLACED IN CCU. IT IS UNKNOWN THE LENGTH OF TIME THE PATIENT WAS IN CCU. THE PATIENT HAS SINCE BEEN RELEASED AND DISCHARGED HOME. 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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention