BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3721263 · Received March 13, 2014

    Report

    Report Number
    3001845648-2014-00048
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 12, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A POSSIBLE CAUSE OF THIS NEEDLE BREAKAGE MAY BE DUE TO THE NEEDLE KINKING WITHIN THE HANDLE. THE NEEDLE CAN KINK WITHIN THE HANDLE IF THE LESION BEING PUNCTURED IS A HARD LESION AND REQUIRES A PARTICULARLY FORCEFUL ADVANCEMENT OF THE NEEDLE. THIS TYPE OF FAILURE CAN OCCUR AT EITHER THE PROXIMAL OR DISTAL END OF THE DEVICE HANDLE. AS THE NEEDLE IS ADVANCED/RETRACTED DURING THE PROCEDURE IT IS POSSIBLE A NEEDLE KINK CAN RESULT IN A BREAKAGE. HOWEVER, AS THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF THIS COMPLAINT. THE RELEVANT PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT ISSUE. THERE WERE NO ECHO-25 (ECHO) DEVICES OF LOT #C921766 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT # SPECIFIED ABOVE DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT WAS CONFIRMED THAT NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE NOTES SECTION OF THE INSTRUCTIONS FOR THE USE 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". COMPLAINTS OF THIS NATURE WIL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING THE SAME CASE, TWO NEEDLES BROKE. THE NEEDLE BROKE IN THE CATHETER. COMPLAINT INFO RECEIVED INDICATED THE NEEDLE BREAKAGE OCCURED NEAR THE HANDLE. AS TWO DEVICES ARE REPORTED AS BEING INVOLVED IN THIS COMPLAINT EVENT A SECOND RELATED REPORT HAS ALSO BEEN SUBMITTED. REFERENCE REPORT #3001845648-2014-00047. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150357 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C921766

    Patients

    Seq Age Sex Outcome Treatment
    1