BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER-SHIELD® II ENDOTRACHAEL TUBE

    MDR report key: 4799942 · Received May 27, 2015

    Report

    Report Number
    1045254-2015-00183
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GEX
    PMA / PMN Number
    K901016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. AS RECEIVED CONDITION: RECEIVED 1 SAMPLE(S), PART NUMBER 7060400, FROM LOT NUMBER 0206201103; NO EVIDENCE OF BIOLOGICAL CONTAMINANTS COULD BE FOUND. THERE WAS NO DAMAGE TO THE PACKAGING THAT WOULD INDICATE A PROBABLE CAUSE. USING AIR AND A SYRINGE IT WAS VERIFIED THERE WAS A VERY SLOW LEAK IN THE TUBE WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT [INJECTING WATER WOULD HAVE BEEN MORE OBVIOUS]. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE SCRAPES ALONG THE LENGTH OF THE TUBE LEADING UP TO THE 2 HOLES MEASURING LESS THAN 0.01¿ IN DIAMETER IN THE CUFF WHICH CAUSED THE LEAK. IT CANNOT BE DETERMINED WHEN THE DAMAGE OCCURRED THEREFORE MANUFACTURING AND MISHANDLING CANNOT BE RULED OUT AS LIKELY CAUSES. COMPLAINT CONFIRMED FOR THE ALLEGED MALFUNCTION [LEAKING DURING PREPARATION].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿DURING PREPARATION, LEAKING HAS BEEN FOUND.¿ THE DEVICE WAS NOT USED ON THE PATIENT; THEREFORE, THERE IS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342759 LASER-SHIELD® II ENDOTRACHAEL TUBE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC XOMED INC. 7060400 0206201103

    Patients

    Seq Age Sex Outcome Treatment
    1