BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CLIP APPL/REMVR 90 MM RND HANDLE VAR

    MDR report key: 3931348 · Received June 24, 2014

    Report

    Report Number
    1045834-2013-16481
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PETER LAZIC GMBH
    Product Code
    HCI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. (B)(4) IS THE IMPORTER OF THE DEVICE. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE'S JAWS WOULD NOT CLOSE. IT IS UNK IF THE EVENT OCCURRED DURING SURGERY, HOWEVER, IT IS KNOWN THAT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED TO HAVE OCCURRED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367187 L-CLIP APPL/REMVR 90 MM RND HANDLE VAR NONE HCI PETER LAZIC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1