BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1022757 · Received March 19, 2008

    Report

    Report Number
    1527736-2008-01665
    Event Type
    Injury
    Date Received
    March 19, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 03/19/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HYSTERECTOMY PROCEDURE, THE JAWS OF THE DEVICE GOT STUCK ON THE TISSUE. THE SURGEON HAD TO CUT THE DEVICE OFF THE TISSUE. THERE WAS SOME BLEEDING, QUANTITY NOT KNOWN. THE PT DID NOT REQUIRE BLOOD PRODUCTS. COMPLETED THE PROCEDURE BY SUTURING. THE PT IS CURRENTLY STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention