BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON VICRYL

    MDR report key: 2634269 · Received June 25, 2012

    Report

    Report Number
    MW5025977
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 25, 2012
    Manufacturer
    ETHICON INC, ATTN. WCO
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ABOUT 3/4 OF AN 0-VICRYL, UR-6 SUTURE NEEDLE BROKE OFF AS THE SURGEON WAS ABOUT TO SUTURE A LAPAROSCOPIC INCISION SITE. THE SURGEON CALLED FOR X-RAY C-ARM TO LOCATE THE NEEDLE AND FOUND IT EMBEDDED IN THE ABDOMINAL WALL/MUSCLE TISSUE. THE SURGEON THEN WENT ON TO RETRIEVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON VICRYL ETHICON VICRYL GAM ETHICON INC, ATTN. WCO J 603 EEM 950

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other