BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 1871461 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05894
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) .INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE TO FOUR DAYS POST OF A LAPAROSCOPIC CHOLECYSTECTOMY THE PATIENT RETURNED TO THE ER PRESENTING WITH PAIN AND VOMITING. PRIOR TO THE PATIENT RETURNING THE SURGEON HAD PLACED A DRAIN DURING THE ORIGINAL PROCEDURE DUE TO THE PATIENT HAD PANCREATITIS; THE DRAIN WAS REMOVED 24 HOURS POST OP AND THE PATIENT WAS RELEASED HOME AT THAT TIME. THE SURGEON PERFORMED AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON THE PATIENT WHEN THEY RETURNED AND DECIDED TO PLACE A DRAIN DUE TO A BILE LEAK FOUND AFTER TESTING. THE (ERCP) PROCEDURE WAS PERFORMED IN THE ENDOSCOPY SUITE. IT IS NOT KNOWN IF THE PATIENT WAS ADMITTED OR RELEASED HOME.

    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