BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCI - TUMESCENT CATHETER INVERSION SYSTEM

    MDR report key: 841421 · Received April 24, 2007

    Report

    Report Number
    1216828-2007-00025
    Event Type
    Malfunction
    Date Received
    April 24, 2007
    Date of Event
    March 19, 2007
    Report Date
    April 20, 2007
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    GAJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING THE CASE, THE SURGEON WAS STRIPPING THE VEIN AND THE GREEN TIP OF THE CATHETER CAME OFF AND REMAINS IN THE PATIENT. SALES REP INDICATED, THE GREEN PIECE INSIDE THE PATIENT WILL NOT BE REMOVED. THE DOCTOR STATED, THE MATERIAL INSIDE THE PATIENT IS STERILE. THE DOCTOR WAS ASKED IF HE WANTED TO DO AN ULTRASOUND TO LOCATE THE MATERIAL, BUT REFUSED. THERE WILL BE NO REMOVAL OF THE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCI - TUMESCENT CATHETER INVERSION SYSTEM NONE GAJ SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7210023 60849013

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR