BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 18757758 · Received February 22, 2024

    Report

    Report Number
    3001845648-2024-00065
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    August 27, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. IN THE ADDITIONAL INFORMATION PROVIDED THE CUSTOMER STATED THAT THE PICTURES ARE ATTACHED BUT NO ACTUAL PICTURE WAS PROVIDED. CLARIFICATION WAS SENT AS FOLLOW: ¿COULD YOU ALSO PLEASE PROVIDE THE PICTURES FROM CUSTOMER.¿ REPLY WAS RECEIVED AS FOLLOW: ¿SORRY FOR CONFUSION, LOCAL REP. HAS CONFIRMED THAT THERE IS NO PHOTO FOR THIS PR.¿ THEREFORE, THE INVESTIGATION WAS COMPLETED BASED ON CUSTOMER AND/OR REP TESTIMONY. SHOULD THE DEVICE OR IMAGES BECOME AVAILABLE IN THE FUTURE, THE FILE WILL BE UPDATED ACCORDINGLY. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C DEVICE OF LOT NUMBER 2080508 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077 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". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0077) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS NO DEVICE WAS RETURNED FOR EVALUATION AND NO IMAGES WAS SHARED A POSSIBLE ROOT CAUSE IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO THE DEVICE COMING INTO CONTACT WITH A HARD LESION DURING THE FIRST SUCCESSFUL PASS LEADING TO THE DISTAL END OF THE NEEDLE BEND REPORTED. THIS NEEDLE KINK WOULD HAVE CAUSED THE NEEDLE ADVANCEMENT/RETRACTION DIFFICULTY ENCOUNTERED BY THE USER DURING SECOND PUNCTURE ATTEMPT AS STATED IN THE DESCRIPTION OF THE EVENT ¿DURING SECOND PUNCTURE BY DEVICE THE DOCTOR FELT RESISTANCE IN ADVANCING. HE FOUND THE NEEDLE DEFORMED (IT SHOWS L SHAPE) AFTER WITHDREW THE DEVICE.¿ SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. NO PATIENT OUTCOME INFORMATION WAS SHARED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DURING SECOND PUNCTURE BY DEVICE THE DOCTOR FELT RESISTANCE IN ADVANCING. HE FOUND THE NEEDLE DEFORMED(IT SHOWS L SHAPE) AFTER WITHDREW THE DEVICE. THE PROCEDURE HAS COMPLETED BUT THE SPECIMEN WAS NOT ENOUGH TO EXAMINE DUE TO THE DEFORMED DEVICE. PATIENT/EVENT INFO - NOTES: C5,,7,8,10,11, ALL "NO".

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 27-AUG-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642848 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2080508 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male