BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPRO CLIP LIG APPLIER

    MDR report key: 1201572 · Received October 17, 2008

    Report

    Report Number
    1219930-2008-00745
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDO
    PMA / PMN Number
    K925602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. PT GENDER: UNK. ACCORDING TO THE RPTR: THE DEVICE DOESN'T WORK SINCE THE CENTRAL ROD WAS DAMAGED DURING STERILIZATION. AS A RESULT, THE CLIPS DO NOT RELEASE FROM THE CARTRIDGE AND THE TISSUE GETS PULLED WHEN THE DEVICE IS BEING REMOVED FROM THE PT. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPRO CLIP LIG APPLIER DISPOSABLE SURGICAL CLIP APPLIER GDO NORTH HAVEN - USS C2G3101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROD ID: 8886848812