BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLASSIC PLUS NEEDE HOLDER, STERNAL, 7 IN, 178 MM

    MDR report key: 7682519 · Received July 2, 2018

    Report

    Report Number
    7682519
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 29, 2018
    Manufacturer
    SYMMETRY SURGICAL, INC. (OEM)
    Product Code
    HRQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SMALL METAL TIP BROKE OFF OF A NEEDLE HOLDER USED DURING A MITRAL VALVE REPAIR. THIS WAS NOT REVEALED UNTIL A POSTOPERATIVE CHEST X-RAY. THE PT REQUIRED SURGICAL INTERVENTION TO REMOVE THE RETAINED FOREIGN OBJECT. THE DEVICE WAS MANUFACTURED BY SYMMETRY SURGICAL, INC., AND SERVICED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499434 CLASSIC PLUS NEEDE HOLDER, STERNAL, 7 IN, 178 MM NEEDLE HOLDER / HEMOSTAT HRQ SYMMETRY SURGICAL, INC. (OEM)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention