BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARADY VEIN HOOK

    MDR report key: 10232542 · Received July 6, 2020

    Report

    Report Number
    10232542
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 24, 2020
    Report Date
    June 30, 2020
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    GAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE MEDIUM CROCHET VEIN HOOK BROKE OFF INTO THE PATIENT ON FIRST PASS. STAFF SURGEON IMMEDIATELY AWARE AND LOOKED FOR PIECE AT THE SURGICAL SITE AND ON THE SURGICAL FIELD USING BOTH VISUAL INSPECTION AND VASCULAR ULTRASOUND INSPECTION. SURGICAL TEAM SEARCHED THE SURGICAL FIELD. CIRCULATOR SEARCHED THE OPERATING ROOM FLOOR VISUALLY AND WITH A MAGNET BROOM. THE TIP OF THE CROCHET VEIN HOOK WAS NOT LOCATED. SURGEON COMMENTED THAT SHE WOULD BE INFORMING THE PATIENT. THIS IS AT LEAST THE FOURTH PATIENT THAT THIS HAS HAPPENED TO AND PREVIOUS PATIENTS WE WERE ABLE TO FIND THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699261 VARADY VEIN HOOK STRIPPER, VEIN, REUSABLE GAI AESCULAP IMPLANT SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA