BEUDAMED
    FDA Adverse Event Other Summary report: N

    VOCAL FOLD LIGHT CARRIER

    MDR report key: 1213884 · Received October 27, 2008

    Report

    Report Number
    1225968-2008-00001
    Event Type
    Other
    Date Received
    October 27, 2008
    Date of Event
    July 28, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ENDOCRAFT, LLC
    Product Code
    KAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH WAS RECENTLY FILED BY THE (B) (6) HOSPITAL FOR AN EVENT IN WHICH A LIGHT CARRIER WAS RESPONSIBLE FOR A FIRST-SECOND DEGREE BURN TO THE SKIN ON A PT'S LIP BUT NOT INVOLVING THE VERMILLION BORDER. THE LIGHT CARRIER WAS RETURNED TO ENDOCRAFT FOR EVALUATION ON (B) (6) 2008, AND THE LIGHT CANNULA WAS CLEARLY DAMAGED IN A WAY SUGGESTING MISUSE, AS THE LIGHT CARRIER WAS SEVERELY BENT (ALMOST FOLDED IN HALF, WITH APPROX 70% OF THE FIBER OPTICS DESTROYED. A PHOTOGRAPH OF THE RETURNED LIGHT CARRIER IS PROVIDED ALONG WITH AN UNUSED LIGHT CARRIER AND IS ATTACHED TO THIS MDR. IN ADDITION TO THE DAMAGED LIGHT SOURCE, ENDOCRAFT CONCLUDED THAT THE CLINICIAN MISUSED THE DEVICE AND DID NOT FOLLOW COMMON PRACTICE OR THE SPECIFIC INSTRUCTIONS FOR USE ACCOMPANYING THE UNIVERSAL MODULAR GLOTTISCOPE. THOSE INSTRUCTIONS EXPLICITLY DELINEATE THAT THE LIGHT CARRIER SHOULD NOT BE IN CONTACT WITH PTS' SKIN AND THAT MOIST GAUZE SHOULD BE PLACED BETWEEN THE LIGHT CARRIER AND THE PT'S SKIN, WHICH PRECLUDES THE TYPE OF INJURY SUSTAINED IN THIS REPORT. IF THE INSTRUCTIONS HAD BEEN ADHERED TO, THE BURNING OF THE PT'S LIP WOULD NOT HAVE OCCURRED. ALSO, THE CONDITION AND BENDING OF THE LIGHT CARRIER ALLOWED FOR THE SKIN CONTACT AND SUGGESTED FURTHER MISUSE.

    Description of Event or Problem · 1

    PT HAVING A MICROSURGICAL LARYNGOSCOPY WITH A STAGE EXCISION OF LEFT VOCAL FOLD PAPILLOMA. A LIGHT SOURCE WITH THE LIGHT SOURCE CARRIER WAS BEING USED. LIGHT SOURCE SETTING WAS AT 100%. DURING CASE THE PT'S RIGHT UPPER LIP WAS NOTED TO BE SWOLLEN WITH EXUDATES. LIGHT SOURCE AND THE LIGHT SOURCE CARRIER IN THE LARYNGOSCOPE WERE REMOVED AND LIP EXAMINED. A FIRST-SECOND DEGREE BURN WAS PRESENT ON THE RIGHT UPPER LIP NOT AFFECTING THE VERMILLION BORDER. IMMEDIATELY ICE WAS APPLIED FOLLOWED BY TOPICAL BACITRACIN OINTMENT. AT END OF PROCEDURE PT WAS TRANSFERRED TO THE POST ANESTHESIA CARE UNIT IN SATISFACTORY CONDITION. PT DISCHARGED WITH INSTRUCTIONS TO CONTINUE ICE, APPLY BACITRACIN AND TO SEE PLASTIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCAL FOLD LIGHT CARRIER LIGHT CARRIER KAA ENDOCRAFT, LLC UMG 105LCN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MODEL #20132120, SERIAL NUMBER (B) (4), LOT| KARL STORZ BIFURCATED LIGHT CABLE 495UD| NUMBER BB02