BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE PDB

    MDR report key: 3082107 · Received April 19, 2013

    Report

    Report Number
    3082107
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    COVIDIEN LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN INSERTED THE TROCAR AND INFLATED THE BALLOON. HE MANIPULATED THE TROCAR A SMALL AMOUNT AND THERE WAS AN AUDIBLE "POP" SOUND. THE PHYSICIAN CONTINUED THE PROCEDURE WITHOUT THE TROCAR. WHEN INSERTING THE MESH, THE PHYSICIAN NOTED THAT A PIECE OF THE TROCAR BALLOON WAS LODGED IN THE PATIENT. HE WAS ABLE TO REMOVE THE PIECES WITHOUT INJURY TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT INGUINAL HERNIA REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169462 AUTOSUTURE PDB TROCAR, PERITONEAL DISTENSION BALLOON GCJ COVIDIEN LLC PDB10000 P2M0247

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES