BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM

    MDR report key: 3883154 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00091
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    November 10, 2014
    Report Date
    February 17, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HCH
    PMA / PMN Number
    K833650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    G5: K833652. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: ALL PERMANENT CLIPS ARE TESTED REGARDING THEIR CLOSING FORCE. THE DATE OF THE AFFECTED BATCH WAS REVIEWED AND FOUND TO BE FULLY ACCORDING TO THE SPECIFICATIONS. THERE ARE NO HINTS FOR MATERIAL OR PRODUCT DEVIATIONS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING PLACEMENT OF THE CLIP AT THE ANEURYSM, IT DID NOT COMPLETELY CLOSE. CLIP WAS REMOVED AND REPLACED BY A FUNCTIONAL CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105898 YASARGIL PERM MINI-CLIP SLT-CVD 4.7MM HCH AESCULAP AG & CO. KG FE712K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other