BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPILOT VL

    MDR report key: 4170308 · Received September 25, 2014

    Report

    Report Number
    3008910264-2014-00001
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MAGAW MEDICAL
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO REGARDING THE PT INJURY WAS UNAVAILABLE AFTER ATTEMPTS TO REACH REPORTING PHYSICIAN. IT IS UNK IF THE INJURY WAS CAUSED BY THE DISPOSABLE SHEATH, AN ENDOTRACHEAL TUBE, AN ENDOTRACHEAL TUBE INTRODUCER, OR FROM MULTIPLE ATTEMPTS AT LARYNGOSCOPY. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO EVIDENCE OF DEFECTIVE OR DAMAGED DEVICE COMPONENTS. ATTEMPTS TO CONTACT THE REPORTING PHYSICIAN BY PHONE WERE MADE ON (B)(6) 2014.

    Description of Event or Problem · 1

    AFTER DIFFICULT INTUBATION, 3 LACERATIONS WERE NOTED TO PATIENT'S SOFT PALATE. THE MOST SEVERE LACERATION WAS 3 CM LONG AND 0.5 CM DEEP AND REQUIRED 3 SUTURES TO CLOSE (CLOSED BY SURGEON). PT REMAINED IN HOSP OVERNIGHT FOR OBSERVATION. NO FURTHER SEQUELAE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596818 COPILOT VL VIDEO LARYNGOSCOPE CCW MAGAW MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization