BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9543534 · Received January 3, 2020

    Report

    Report Number
    3002808486-2020-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 5, 2019
    Report Date
    July 15, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002236462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE DISTAL END OF THE FROVA DEVICE FRACTURED, WHEN INSERTED WITH LARYNGOSCOPE. THE PROCEDURE WAS COMPLETED WITH CONVENTIONAL ENDOTRACHEAL INTUBATION, CAUSING PROLONGED PROCEDURE. ONLY VERY LIMITED INFORMATION WAS PROVIDED AND SINCE THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DISTAL END TO FRACTURE, WHEN INSERTED WITH AN UNKNOWN LARYNGOSCOPE. ACCORDING TO THE INSTRUCTIONS FOR USE IT IS CONTRAINDICATED NOT TO USE THE FROVA DEVICE ¿IF THE EPIGLOTTIS CANNOT BE VISUALIZED WHEN PERFORMING LARYNGOSCOPY, I.E. GRADE IV CORMACK & LEHANE LARYNGOSCOPY CLASSIFICATION.¿ AND UNDER INSTRUCTIONS FOR USE: USING LARYNGOSCOPY, INTRODUCE THE TIP OF THE CATHETER INTRODUCER BEYOND THE EPIGLOTTIS AND ADVANCE IT IN A STRAIGHT LINE TOWARDS THE GLOTTIS. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). 510(K): K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE TIME OF INSERTION WITH THE HELP OF LARYNGOSCOPE THE DISTAL END WAS FRACTURED. FRACTURED NEAR THE TIP AND THEN PROCEDURE WAS COMPLETED IN CONVENTIONAL WAY OF INTUBATION. PATIENT OUTCOME: THE PRODUCT DID CAUSE/CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE: CONVENTIONAL ENDOTRACHEAL INTUBATION. PLEASE SPECIFY ADVERSE EFFECT(S) AND PROVIDE DETAILS: DELAY IN THE TIME FOR SECURING AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10279 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G23646 E3857801 00827002236462

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR