BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7821899 · Received August 28, 2018

    Report

    Report Number
    3001845648-2018-00401
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 28, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K083330. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED. INITIALLY THIS REPORT WAS CONSERVATIVELY ASSESSED AS A PROXIMAL SHEATH KINK THAT HAS A RISK ASSOCIATED WITH IT THAT IS NOT REMOTE. UPON RECEIPT OF THE DEVICE THE SHEATH WAS DAMAGED DISTALLY AND NO KINK WAS CONFIRMED THEREFORE THE UPDATED FAILURE MODE ASSIGNED IS CATEGORIZED AS LOW RISK AND THEREFORE NO LONGER MEETS THE FDA MALFUNCTION REPORTING CRITERIA. NO PRECEDENCE EXISTS FOR THIS EVENT AND NO PATIENT INJURY OCCURRED.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K083330. 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) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED. INITIALLY THIS REPORT WAS CONSERVATIVELY ASSESSED AS A PROXIMAL SHEATH KINK THAT HAS A RISK ASSOCIATED WITH IT THAT IS NOT REMOTE. UPON RECEIPT OF THE DEVICE THE SHEATH WAS DAMAGED DISTALLY AND NO KINK WAS CONFIRMED THEREFORE THE UPDATED FAILURE MODE ASSIGNED IS CATEGORIZED AS LOW RISK AND THEREFORE NO LONGER MEETS THE FDA MALFUNCTION REPORTING CRITERIA. NO PRECEDENCE EXISTS FOR THIS EVENT AND NO PATIENT INJURY OCCURRED.

    Description of Event or Problem · 0

    THE USER OPENED THE PACKAGE AND CHECK THE INTEGRITY OF THE DEVICE AND FOUND OUT THE TIP OF THE SHEATH BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665774 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1474489 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1