BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0 VICRYL SUTURE UR - 6

    MDR report key: 4093713 · Received September 15, 2014

    Report

    Report Number
    4093713
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR A LAPAROSCOPIC CHOLECYSTECTOMY. THE SURGEON WAS USING A 0 VICRYL ON A UR-6 NEEDLE TO SECURE THE HASSAN PORT WHEN THE NEEDLE BROKE IN HALF AND HALF WAS RETAINED IN THE PATIENT. THE SURGEON USED FLUORO GUIDANCE TO REMOVE THE BROKEN HALF OF NEEDLE FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570245 0 VICRYL SUTURE UR - 6 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON, INC. * HG6486

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NON KNOWN