BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX 5MM ENDO CLIP APPLIER

    MDR report key: 1081512 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00662
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 7, 2008
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/24/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MFG RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE JAWS OF THE DEVICE AND CLIP JAMMED ON THE VESSEL. THE DEVICE WAS PULLED OFF CAUSING BLEEDING. ANOTHER TYPE OF DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other