BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6141165

    MDR report key: 6141165 · Received December 2, 2016

    Report

    Report Number
    6141165
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 14, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT THE END OF SURGERY, THE PATIENT WAS UNABLE TO BE EXTUBATED BY CERTIFIED REGISTERED NURSE ANESTHESIOLOGIST (CRNA) DUE TO A MECHANICAL OBSTRUCTION. THE ANESTHESIOLOGIST, CRNA, AND SURGEON WERE PRESENT AT THE INCIDENT. BRONCHOSCOPY AND VIDEO GLIDESCOPE WERE PERFORMED. WHEN THE PATIENT WAS EXTUBATED BY ENT PHYSICIAN, THERE WAS A NOTABLE CUFF OF PLASTIC PRESENT DISTAL TO NIM CUFF. THERE HAD BEEN NO DIFFICULTY OR ANY ISSUE INTUBATING PATIENT DURING INDUCTION. NOTES FROM THE OPERATIVE NOTE: THE PATIENT "WAS REVERSED FROM ANESTHESIA AND EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AT THE TIME OF EXTUBATION, THERE WAS A SMALL AMOUNT OF RESISTANCE AS THE TUBE WAS BEING REMOVED; THEREFORE, WILL BE UTILIZED KALEIDOSCOPE TO VISUALIZE THE AREA AND THE ENDOTRACHEAL TUBE HAD DEVELOPED AN UNUSUAL CUFF OF PLASTIC JUST DISTAL TO THE BALLOON, THEREFORE IT WAS EASILY REMOVED BY SIMPLY ROCKING IT OUT IN A CORKSCREW FASHION, LEFT SIDE FIRST, THE RIGHT AND CAME WITHOUT RESISTANCE OR HAD ANY EVIDENCE OF TRAUMA TO THE VOCAL FOLDS. APPEARED TO BE A SMALL DEFECT IN THE ENDOTRACHEAL TUBE, WHICH SHOULD CAUSE NO DIFFICULTY WITH VOCAL QUALITY...IN THE RECOVERY ROOM, THE PATIENT HAS NORMAL VOICE."

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR