BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX

    MDR report key: 1833241 · Received September 8, 2010

    Report

    Report Number
    MW5017370
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    April 6, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ETHICON ENDOSURGERY, DIV OF JOHNSON & JOHNSON
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD GALLBLADDER SURGERY USING THE ETHICON, LIGAMAX 5 MM CLIP APPLIER. THE SURGEON HAD SIGNIFICANT DIFFICULTY GETTING THE APPLIER TO OPEN AND RELEASE CLAMP PLACED ON TISSUE. A SECOND LIGAMAX 5 MM CLIP APPLIER WAS THEN USED BUT THE SURGEON ENCOUNTERED THE SAME PROBLEM. ON (B)(6) 2010, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH SEPSIS. SHE WAS TRANSFERRED TO A TERTIERY HOSPITAL IN WHICH A BILIARY STENT WAS PLACED. THE DEVICES WERE GIVEN TO THE REPRESENTATIVE FROM ETHICON WHO RELATED THAT THE COMPANY HAD EXPERIENCED OTHER PROBLEMS WITH THE SAME TYPE OF DEVICE. IT WAS BELIEVED THAT IN ATTEMPTING TO DISENGAGE THE DEVICE THE BILIARY DUCT WAS LACERATED. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CHRONIC CHOLECYSTITIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES. EVENT REAPPEARED AFTER REINTRODUCTION?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDOSURGERY, DIV OF JOHNSON & JOHNSON LIGAMAX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization