BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 8211841 · Received January 3, 2019

    Report

    Report Number
    3002808486-2018-01531
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    November 30, 2018
    Report Date
    March 4, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ¿EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): E597079 (K161813). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# PR248548. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT A VERY SMALL PART OF THE FROVA DETACHED WHEN IT USED WITH A CARLENS INTUBATION PROBE. THE SMALL PART WAS REMOVED WITH FIBROSCOPY WITHOUT ANY HARM TO THE PATIENT. NO PRODUCT WAS RETURNED TO ASSIST THE INVESTIGATION, BUT THE PHOTO PROVIDED CONFIRMED A SMALL PART HAD FLAKED OFF OF THE FROVA DEVICE. HOWEVER, IT IS REPORTED THAT IT OCCURRED WHILE USED WITH A CARLENS TUBE, WHICH APPARENTLY IS A DOUBLE LUMEN TUBE AND THE FROVA INTRODUCER IS DESIGNED FOR PLACEMENT OF A SINGLE LUMEN TUBE ONLY. ALSO, SINCE REPORTED THAT THE FROVA WAS USED WITH A CARLENS TUBE, IT IS ASSUMED THAT THE CUSTOMER WAS NOTIFIED OF THE INTENDED USE, TOO. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED. 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

    DURING REMOVAL OF THE BLUE MANDRIL FOR DIFFICULT INTUBATION THE FROVA WAS USED THROUGH A SELECTIVE INTUBATION PROBE (TYPE CARLENS), ITS EXTREMITY WAS PROPPED FROM FROVA, DESPITE LUBRICATION OF THE FROVA MANDRIL, A VERY SMALL PART DETACHED AU VUE IN LIGHT OF THE FIBROSCOPY. IT WAS REMOVED WITH THE FIBROSCOPY. NO PATIENT INJURY.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5248 FROVA INTUBATING INTRODUCER BTR TUBE, TRACHEAL (W/WO CONNECTOR) BTR WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1