BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII PIOS FIRST ENTRY 5X100

    MDR report key: 6197979 · Received December 20, 2016

    Report

    Report Number
    MW5066836
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 20, 2016
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 5MM TROCAR INNER SLEEVE, WHICH IS CLOSED BUT DOES HAVE SMALL HOLES IN THE INNER SLEEVE, HAD A PIECE OF SOMETHING BLACK INSIDE THE TROCAR. THE ENTIRE TROCAR AND PACKAGE WERE TAKEN TO THE SPD MANAGER. TROCAR WAS REPLACED BUT THE PATIENT WILL HAVE TO BE MONITORED FOR INFECTION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840277 KII PIOS FIRST ENTRY 5X100 KII PIOS FIRST ENTRY 5X100 GCJ APPLIED MEDICAL 1273992

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR LAPAROSCOPIC VENTRAL WALL HERNIA REPAIR WITH BARD| ROUND 11.4CM MESH USING THE ECHO SYSTEM.