BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YASARGIL CLIP

    MDR report key: 8058151 · Received November 10, 2018

    Report

    Report Number
    8010099-2018-00005
    Event Type
    Malfunction
    Date Received
    November 10, 2018
    Report Date
    November 10, 2018
    Manufacturer
    MEDICON E.G.
    Product Code
    HCH
    UDI-DI
    04046826094171
    PMA / PMN Number
    K010908
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE JAW OF THE CLIP WAS MISALIGNED, WHICH CAN ONLY BE CAUSED BY APPLYING GREAT EXTERNAL FORCE TO THE JAW. CLOSING FUNCTION WAS IMPAIRED. THE STATE OF THE DEVICE INDICATES IMPROPER HANDLING DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    APPLICATION OF EXCESSIVE FORCE TO THE JAW PART OF THE CLIP DURING A SURGICAL PROCEDURE CAUSED CLIP JAW MISALIGNMENT AND IMPAIRED CLIP FUNCTION BY MAKING IT IMPOSSIBLE TO CLOSE THE CLIP PROPERLY. THE PATIENT DID NOT SUFFER ANY HARM. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE DISTRIBUTOR, WHO FIRST INDICATED THAT THE MALFUNCTION OCCURRED DURING USE OF THE DEVICE, AND THEN THAT IT WAS DAMAGED DURING CLEANING AND STERILIZATION PRIOR TO FIRST USE. THE SECOND STATEMENT DOES NOT HOLD, SINCE THE RETURNED DEVICE SHOWED TRACES OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897506 YASARGIL CLIP ANEURYSM CLIP HCH MEDICON E.G. Q388286 04046826094171

    Patients

    Seq Age Sex Outcome Treatment
    1