BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-MINI CLIP TEMP STR 3 MM NARROW JAW

    MDR report key: 3747873 · Received November 27, 2013

    Report

    Report Number
    1045834-2013-14214
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Report Date
    February 20, 2012
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORT REC'D FROM THE (B)(6) STATING THAT THE DEVICE "DID NOT FULLY CLOSE OFF VESSEL DURING ANEURYSM CLIPPING." THE DEVICE WAS USED DURING A SURGICAL PROCEDURE. THE DATE OF THE EVENT IS UNK. NO USER OR PT INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619448 Y-MINI CLIP TEMP STR 3 MM NARROW JAW NONE HCH PETER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1