BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CLIP APPL/REMVR 90 MM RND HANDLE VAR

    MDR report key: 3994542 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14846
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    September 21, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. ANSPACH IS THE IMPORTER OF THE DEVICE. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT "AFTER APPLYING TWO CLIPS, THE APPLIER WOULD NOT GRAB THE THIRD CLIP DURING AN ANEURYSM SURGERY". NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663248 L-CLIP APPL/REMVR 90 MM RND HANDLE VAR NONE HCI PETER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1