BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YASARGIL CLIP

    MDR report key: 8058035 · Received November 10, 2018

    Report

    Report Number
    8010099-2018-00004
    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 CLIP BRACE WAS SLIGHTLY BENT AND HAD BROKEN NEAR ONE END. CLOSING PRESSURE AND CLOSING FUNCTION WERE FOUND TO BE WITHIN SPECIFICATIONS. THE BENT BRACE AND THE TRACES OF BLOOD FOUND ON THE CLIP INDICATE IMPROPER HANDLING DURING THE SURGICAL PROCEDURE. APPARENTLY FORCE WAS APPLIED TO THE CLIP BY ANOTHER OBJECT, FIRST BENDING AND FINALLY BREAKING THE BRACE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, UNDUE FORCE SEEMS TO HAVE BEEN APPLIED TO THE CLIP WITH A FOREIGN OBJECT, LEADING TO BREAKAGE. 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 BROKE 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
    897724 YASARGIL CLIP ANEURYSM CLIP HCH MEDICON E.G. O314650 04046826094171

    Patients

    Seq Age Sex Outcome Treatment
    1