BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS BOW

    MDR report key: 7697827 · Received July 18, 2018

    Report

    Report Number
    7697827
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 12, 2018
    Manufacturer
    SUTURE EASE, INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE THIN END OF THE "GRABBER" BROKE OFF INTO THE SURGICAL SITE. A DIFFERENT DEVICE WAS USED TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539287 CROSS BOW SUTURE HCF SUTURE EASE, INC. 1384-1

    Patients

    Seq Age Sex Outcome Treatment
    1