BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9361486 · Received November 22, 2019

    Report

    Report Number
    3002808486-2019-01848
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 15, 2019
    Report Date
    March 10, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    00827002535176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND THREE UNUSED DEVICES. IT WAS REPORTED THAT THE FROVA DEVICE WAS TOO SOFT AND WOULD NOT GO INTO THE TRACHEA. THE PROCEDURE WAS ABANDONED AND ANOTHER TUBE WAS PLACED. THE USED FROVA DEVICE WAS NOT RETURNED, BUT THREE UNOPENED/UNUSED DEVICES FROM THE SAME LOT. THE POUCHES WERE SLIGHTLY DISCOLORED, BUT A THOROUGH INVESTIGATION OF THE THREE DEVICES DID NOT REVEAL ANY NON-CONFORMANCES AND THEY WERE ALL FOUND MANUFACTURED ACCORDING TO SPECIFICATIONS, WITH A SMOOTH SURFACE AND NO SOFT APPEARANCE. THE SPOPS DEVICES ARE CURVED TO FIT IN SLIP PEEL-POUCHES AND EVEN AFTER SLIGHT MANIPULATION THE DEVICES MAINTAINED THEIR CURVE. THEREFORE, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FROVA DEVICE TO APPEAR SOFT AND DIFFICULT TO ADVANCE INTO THE TRACHEA AS REPORTED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. 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

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K161813. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: CASE OF A DIFFICULT INTUBATION PLANNED FOR AN OBESE PATIENT, HERE IS THE PROCEDURE: USING A VIDEO BLADE FROM ANOTHER MANUFACTURER: NOTHING TO REPORT. THE TRACHEAL TUBE IS NOT POSITIONED CORRECTLY TO INTUBATE USE OF THE FROVA, IT DID NOT GO INTO THE TRACHEA. GOOD VISUALIZATION OF THE VOCAL CORDS BUT THE MANDREL COULD NOT BE SET UP. ABANDONMENT OF THIS TECHNIQUE. USE OF AN ARTICULATED BLADE AND SIMPLE INTUBATION MANDREL. IT IS THE SECOND COMPLAINT WITH THE SAME PROBLEM THE FROVA IS TOO SOFT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156430 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE G53517 E3880024 00827002535176

    Patients

    Seq Age Sex Outcome Treatment
    1