BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 16395362 · Received February 17, 2023

    Report

    Report Number
    3001845648-2023-00114
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 18, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT DOES NOT RELATE TO A SPECIFIC RPN BUT DOES STATE THAT THE NEEDLE BROKE OFF INSIDE PATIENT¿S TRACHEA DURING AN EBUS PROCEDURE, THEREFORE THE DEVICE RPN WOULD HAVE TO BE FROM ONE OF THE ECHO-HD-EBUS-O, ECHO-HD-EBUS-O-C, ECHO-HD-EBUS-P OR ECHO-HD-EBUS-P-C PRODUCT FAMILIES. LAB EVALUATION: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO EBUS-O AND ALL ECHO-P DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. PRIOR TO DISTRIBUTION, ALL ECHO EBUS-O-C AND ALL ECHO-P-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL . AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THE DEVICES INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS NO ADDITIONAL INFORMATION WAS SHARED A POSSIBLE ROOT CAUSE IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO ADVANCEMENT THROUGH HARD TISSUE SUCH AS CARTILAGE RINGS OF THE TRACHEA WHICH COULD CAUSE THE DISTAL END OF THE NEEDLE TO BREAK ON THE PUNCTURE ATTEMPT AS IT WAS STATED IN THE COMPLAINT DESCRIPTION THAT ¿NEEDLE BREAK OFF INSIDE PATIENTS TRACHEA DURING AN EBUS PROCEDURE¿. THE COMPLAINT INFORMATION INDICATED THAT THE ISSUE WAS RELATED TO EBUS NEEDLES BUT DID NOT SPECIFY IF THEY WERE EBUS ULTRA OR EBUS PROCORE, SO AN ANALYSIS FOR THE LAST 3 YEARS FOR DISTAL NEEDLE BREAK COMPLAINTS WAS CARRIED OUT TO DETERMINE IF EBUS ULTRA OR EBUS PROCORE IS THE MOST COMMON. THE ANALYSIS DETERMINED THAT THIS WAS EBUS PROCORE, THEREFORE AS THIS IS THE MOST COMMON PRODUCT FAMILY THIS WAS SELECTED FOR THIS FILE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAD FURTHER TESTS AND WAS GIVEN THE ALL CLEAR. THE BROKEN NEEDLE TIP WAS REMOVED FROM THE PATIENT BY A LOOP CATHETER. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    I SPOKE TO THE CUSTOMER TODAY WHO HAS INFORMED ME THAT THEY HAD AN COOK EBUS NEEDLES BREAK OFF INSIDE PATIENTS TRACHEA DURING AN EBUS PROCEDURE ON THE (B)(6) 2023. NEEDLE FRAGMENT WAS EVENTUALLY REMOVED BY A LOOP CATHETER AS THEY COULD NOT REMOVE IT BY BIOPSY FORCEPS. PATIENT HAD FURTHER TESTS AND WAS GIVEN THE ALL CLEAR. NEEDLE HAS BEEN REPORTED TO MHRA AND HAS BEEN SENT TO CHESTERFIELD ROYAL INVESTIGATION DEPARTMENT AND I WILL NEED TO ARRANGE COLLECTION FROM.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-APR-2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161624 UNKNOWN FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention