BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 8842055 · Received July 30, 2019

    Report

    Report Number
    3001845648-2019-00377
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520127
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K092359. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K092359. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). THE ECHO-HD-19-A DEVICE OF LOT NUMBER: C1588829 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 08AUG2019 AND 18SEP2019. THERE WAS A KINK AT THE DISTAL END OF THE NEEDLE. DAMAGE TO THE SHEATH WAS OBSERVED. NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1588829) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C1588829. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NEEDLE KINKING DISTALLY WHEN ADVANCING THE DEVICE THROUGH THE ENDOSCOPE WHICH WAS IN A TORTUOUS POSITION, WHICH MAY IN TURN HAVE CAUSED THE SHEATH DAMAGE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THERE WAS A KINK AT THE DISTAL END OF THE NEEDLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE DOCTOR INSERTED THE ECHO-HD-19-A THROUGH THE SCOPE. HE ADJUSTED THE ANGLE AND PUSHED THE HANDLE TO PUNCTURE. HOWEVER, THE HANDLE WAS NOT PRESSED WELL AND THE NEEDLE DID NOT COME OUT EITHER. THE NURSE PULLED THE ECHO-HD-19-A OUT AND FOUND THAT SHEATH WAS BROKEN. THE END OF THE SHEATH WAS HANGING BROKEN. THE DOCTOR GUESSED THE CAUSE OF THE SHEATH BEING BROKEN - WHEN HE PUSHED THE HANDLE, THE NEEDLE PIERCED THE BENT SHEATH. SO SHEATH WAS BROKEN.

    Description of Event or Problem · 0

    THE DOCTOR INSERTED THE ECHO-HD-19-A THROUGH THE SCOPE. HE ADJUSTED THE ANGLE AND PUSHED THE HANDLE TO PUNCTURE. HOWEVER, THE HANDLE WAS NOT PRESSED WELL AND THE NEEDLE DID NOT COME OUT EITHER. THE NURSE PULLED THE ECHO-HD-19-A OUT AND FOUND THAT SHEATH WAS BROKEN. THE END OF THE SHEATH WAS HANGING BROKEN. THE DOCTOR GUESSED THE CAUSE OF THE SHEATH BEING BROKEN, WHEN HE PUSHED THE HANDLE, THE NEEDLE PIERCED THE BENT SHEATH. SO SHEATH WAS BROKEN.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K092359. COOK (B)(4) LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(6) (IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING MANUFACTURER AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE DOCTOR INSERTED THE ECHO-HD-19-A THROUGH THE SCOPE. HE ADJUSTED THE ANGLE AND PUSHED THE HANDLE TO PUNCTURE. HOWEVER, THE HANDLE WAS NOT PRESSED WELL AND THE NEEDLE DID NOT COME OUT EITHER. THE NURSE PULLED THE ECHO-HD-19-A OUT AND FOUND THAT SHEATH WAS BROKEN. THE END OF THE SHEATH WAS HANGING BROKEN. THE DOCTOR GUESSED THE CAUSE OF THE SHEATH BEING BROKEN - WHEN HE PUSHED THE HANDLE, THE NEEDLE PIERCED THE BENT SHEATH. SO SHEATH WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636378 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52012 C1588829 00827002520127

    Patients

    Seq Age Sex Outcome Treatment
    1