BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT

    MDR report key: 4901376 · Received July 1, 2015

    Report

    Report Number
    4901376
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    February 18, 2015
    Report Date
    July 1, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    SURGEON COMPLAINED THAT CASTRO NEEDLE DRIVER (JARIT #121-231) WAS NOT HOLDING SUTURE CORRECTLY. AFTER INSPECTION CASTRO WAS FOUND TO HAVE A FRAGMENT ON THE INSIDE TIP OF THE CASTRO MISSING. FRAGMENT WAS APPROX 3-5 MM IN LENGTH. SURGEON WAS ASKED IF IT HAD BEEN LIKE THAT FOR THE ENTIRE CASE AND HE SAID "I DON'T KNOW" THEREFORE UNSURE WHETHER CASTRO WAS DAMAGED PRIOR TO START OF PROCEDURE OR IF FRAGMENT BROKE OFF DURING PROCEDURE. SURGEON WAS INFORMED OF MISSING FRAGMENT. CHEST X-RAY WAS OFFERED WHICH SURGEON AGREED TO. X-RAY WAS DONE AND READ NEGATIVE FOR ANY RETAINED FRAGMENTS BY THE RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429742 JARIT NEEDLE HOLDER FHQ INTEGRA LIFESCIENCES CORPORATION 121-231 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR