BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2492316 · Received March 13, 2012

    Report

    Report Number
    2134070-2012-00011
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 17, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION REVEALED AN IMPROPER CLIP PINCH DURING TESTING WITH RESPECT TO ONE CLIP. THE DEVICE WAS USED PRIOR TO BEING RETURNED. THE DEVICE PASSED THE VISUAL INSPECTION CRITERIA. EACH CLIP WAS ALIGNED CORRECTLY, AND THE RETAINING CLIP WAS VISIBLE. THE DEVICE WAS FIRED AGAIN AND BOTH CLIPS CAME OUT. THE FIRST CLIP DID FULLY CLIP. THE SECOND CLIP CLIPPED CORRECTLY AND WAS ACCEPTABLE. THE REMAINING CLIPS CAME OUT WITHOUT ANY ISSUE AND WERE ACCEPTABLE. THE DEVICE WAS SENT OUT WITH 16 CLIPS IN IT AND WAS SENT BACK WITH 14. ALL 14 CLIPS WERE FIRED; 13 CLIPS OUT OF 14 WERE ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED AND TORE A BLOOD VESSEL IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS REFUSED BY THE HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA GDO - CLIP APPLIERS NMJ STERILMED, INC. ETHMCM20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention