BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANOSCAN ESO Z CATHETER

    MDR report key: 6156460 · Received December 8, 2016

    Report

    Report Number
    3005344223-2016-00006
    Event Type
    Injury
    Date Received
    December 8, 2016
    Report Date
    November 17, 2016
    Manufacturer
    GIVEN GILA (LOS. ANGELES)
    Product Code
    FFX
    PMA / PMN Number
    K091070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THERE WAS A TEAR AND DAMAGE ON SILICON TUBING AT THE STRAIN RELIEF CARRIER(SRC). THE RULED TUBING AND TIP WERE DISCOLOURED. THERE WAS NO CALIBRATION ERROR. THE DEVICE PASSED THERMAL AND PICOSCOPE TESTS. ALL IMPEDANCE RINGS ARE STABLE & FUNCTIONAL.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING THE PROCEDURE THEY WERE UNABLE TO REMOVE THE CATHETER DURING EXTUBATION AS PATIENT HAD A DEVIATED SEPTUM. THE EARS, NOSE, THROAT DEPARTMENT WAS CALLED TO HELP IN THE REMOVAL OF THE DEVICE. DURING REMOVAL IT WAS NOTICED THE CATHETER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805944 MANOSCAN ESO Z CATHETER SYSTEM, GASTROINTESTIONAL MOTILITY (ELECTRICAL) FFX GIVEN GILA (LOS. ANGELES) 3890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention