BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARNDT ENDOBRONCHIAL BLOCKER SET

    MDR report key: 10870027 · Received November 19, 2020

    Report

    Report Number
    1820334-2020-02163
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    November 13, 2020
    Report Date
    February 22, 2021
    Manufacturer
    COOK INC
    Product Code
    CBI
    UDI-DI
    00827002132801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: G4- DATE RECEIVED BY MANUFACTURER: THE INITIAL DATE REPORTED WAS 16NOV2020. HOWEVER, THIS DATE HAS BEEN UPDATED TO 18NOV2020. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. H6 - METHOD CODE: ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY (4112) INVESTIGATION ¿ EVALUATION. IT WAS REPORTED TO COOK THAT A PRIOR TO USE ARNDT ENDOBRONCHIAL BLOCKER SET (RPN: C-AEBS-5.0-65-SPH FROM LOT# 13314786) ONLY INFLATED ON ONE SIDE OF THE BALLOON. THIS INCIDENT WAS REPORTED BY(B)(6) IN JAPAN ON (B)(6) 2020. FURTHER COMMUNICATION WITH THE USER FACILITY CLARIFIED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER C-AEBS-5.0-65-SPH. NO ADVERSE EFFECTS WERE REPORTED. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST, AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE UNUSED ARNDT ENDOBRONCHIAL BLOCKER WITH PHOTOS WAS RETURNED FOR EVALUATION. NO VISIBLE DAMAGE WAS NOTED TO THE DEVICE. THE BALLOON INFLATED WITHOUT DIFFICULTY; HOWEVER, ONLY ONE SIDE OF THE BALLOON EXPANDED. A DIMENSIONAL VERIFICATION OF THE DEVICE CONFIRMED THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE (DHF) FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 13314786 FOUND ONE RELATED NONCONFORMANCE FOR BALLOON DAMAGE, IN WHICH ONE DEVICE WAS SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT LUMBER. AS ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS ¿INFLATE BALLOON INITIALLY UNDER DIRECT VISION TO ENSURE CORRECT POSITION AND PLACEMENT.¿ INSTRUCTIONS FOR USE ¿FULLY DEFLATE THE BALLOON ON THE ENDOBRONCHIAL BLOCKER.¿ BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE MAIN CAUSE OF FAILURE WAS ATTRIBUTED TO A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IN ADDITIONAL INFORMATION RECEIVED ON 24NOV2020, IT WAS REPORTED THAT A SECOND SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K160542. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF A ARNDT ENDOBRONCHIAL BLOCKER SET WAS NOT ABLE TO INFLATE PROPERLY. THE USER ATTEMPTED TO INFLATE THE BALLOON PRIOR TO PATIENT USE, BUT FOUND THAT ONLY ONE SIDE WAS ABLE TO INFLATE. NO PATIENT CONTACT WAS MADE. ADDITIONAL INFORMATION REGARDING THE DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336689 ARNDT ENDOBRONCHIAL BLOCKER SET CBI TUBE, TRACHEAL/BRONCHIAL CBI COOK INC N/A 13314786 00827002132801

    Patients

    Seq Age Sex Outcome Treatment
    1