BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 18994614 · Received March 28, 2024

    Report

    Report Number
    3001845648-2024-00115
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 29, 2024
    Report Date
    July 30, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF THIS COMPLAINT FILE. THE REPORT WAS GENERATED TO UPDATE PATIENT OUTCOME AND A CODE.

    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. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). THROUGH THE INVESTIGATION IT WAS CONFIRMED THAT DURING THE FIRST PUNCTURE THE NEEDLE TIP WAS BROKEN. THE NEEDLE DEVICE WAS REMOVED FROM THE FUJI SCOPE AND THE DOCTOR ASSUMED THAT THE BROKEN NEEDLE PIECE CAME OUT WITH IT AND FELL TO THE FLOOR WHEN THE DEVICE WAS PULLED OUT OF THE SCOPE. MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O-C OF LOT NUMBER C2121070 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0109 WHICH ACCOMPANIES THIS DEVICE 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¿ AND "THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE TYPE OF SCOPE USED (IFU0109). IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE USER USED THE DEVICE WITH AN INCOMPATIBLE DEVICE, AS PER INFORMATION PROVIDED, A FUJI SCOPE WAS USED AND AS PER IFU ¿THIS DEVICE IS INTENDED FOR USE WITH AN OLYMPUS EBUS SCOPE¿, THEREFORE THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT IS NOT POSSIBLE TO KNOW HOW THE DEVICE PERFORMS WITH AN INCOMPATIBLE DEVICE THEREFORE THE DISTAL NEEDLE BREAK COULD HAVE BEEN INDUCED BY THE SCOPE. IT IS ALSO POSSIBLE THAT HARD LESION MAY HAVE CONTRIBUTED TO THE ISSUE AS IT WAS CONFIRMED THAT THE LYMPH NODE WAS NOT EASY TO PUNCTURE. SUMMARY. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A BRONCHOSCOPY WAS USED TO TRY TO FIND THE BROKEN NEEDLE TIP IN THE AREA OF THE LYMPH NODE BUT THE DOCTOR COULDN'T FIND THE PART OF THE NEEDLE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED FOLLOWING THE RECEIPT OF ADDITIONAL INFORMATION ON 15-APR-2024. PATIENT OUTCOME HAS BEEN UPDATED AS FOLLOWS: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. DR. MAURER ASSUMES THAT THE BROKEN PART OF THE NEEDLE CAME OUT WITH IT WHEN IT WAS PULLED BACK OUT OF THE FUJI DEVICE AND THEN FELL TO THE FLOOR. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DR. MAURER USED A BRONCHOSCOPY TO TRY TO FIND THE BROKEN NEEDLE TIP IN THE AREA OF THE LYMPH NODE. BUT HE COULDN'T FIND THE PART OF THE NEEDLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE ANNEX A CODE HAS BEEN UPDATED BASED ON ADDITIONAL INFORMATION ALSO RECEIVED: WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? FUJIFILM (SN (B)(6)).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 30-JUL-2024.

    Description of Event or Problem · 0

    DURING THE FIRST PUNCTURE, THE ANTERIOR PART OF THE PUNCTURE NEEDLE IS BROKEN OFF "AS PER CC FORM": LAST WEEK WE HAD AN INCIDENT DURING A PUNCTURE WITH THE EBUS NEEDLE. ALREADY DURING THE FIRST PUNCTURE, THE ANTERIOR PART OF THE PUNCTURE NEEDLE IS BROKEN. ACCORDING TO DR. MAURER, THE PUNCTURE ACTUALLY WENT SMOOTHLY AND WITHOUT MUCH RESISTANCE ¿ SO IT IS NOT POSSIBLE TO EXPLAIN WHY THIS HAPPENED. FOR THE FURTHER PUNCTURES WE USED A NEW EBUS NEEDLE, WITHOUT ANY FURTHER PROBLEMS PATIENT OUTCOME A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE BROKEN END OF THE NEEDLE WAS REMOVED WITH PLIERS UNDER OPTICAL CONTROL. IT WAS VERY DIFFICULT, BUT SUCCESSFUL THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE BROKEN PIECE OF THE EBUS NEEDLE HAD TO BE REMOVED WITH PLIERS ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE PATIENT/EVENT INFO - NOTES CLARIFY IF "THE ANTERIOR" PART OF THE NEEDLE IS THE PROXIMAL [USER END] OR DISTAL [PATIENT END]? IT WAS THE DISTAL [PATIENT END]. AS THE DESCRIPTION ON EVENTS IT STATES THAT THE "NEEDLE IS BROKEN OFF" WAS THERE ANY INTERVENTION REQUIRED TO REMOVE THE BROKEN PART OF THE NEEDLE FROM THE PATIENT? AS WAS WRITTEN IN THE COMPLAINT FORM, UNDER POINT C6, THE BROKEN END OF THE NEEDLE WAS REMOVED WITH PLIERS UNDER OPTICAL CONTROL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222003 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2121070 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention