BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 9494434 · Received December 19, 2019

    Report

    Report Number
    3001845648-2019-00763
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Report Date
    February 28, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. (B)(4), 3001845648-2019-00762. 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 . AS THE LOT NUMBER IS UNKNOWN THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS PART OF THE INVESTIGATION. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "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. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. NO ANSWERS TO THE STANDARD ADDITIONAL QUESTIONS WERE RECEIVED MAKING IT VERY DIFFICULT TO DETERMINE A POTENTIAL ROOT CAUSE. BASED ON THE VERY LIMITED INFORMATION SHARED, A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE WHICH CAN BE APPLIED WHEN TRYING TO GET THE NEEDLE OUT OF THE SCOPE DURING ADVANCEMENT, POTENTIALLY RESULTING IN THE SCOPE DAMAGE. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED: "THE DOCTOR COULD NOT ASPIRATE FLUID THROUGH THE FIRST NEEDLE, AS IT BENT EASILY . (B)(4), 3001845648-2019-00762. THE SECOND NEEDLE STIFFENED AND THE DOCTOR PUNCTURED THE SCOPE WHEN TAKING A SPECIMEN OF THE DUODENAL BULB.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K092359. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "THE DOCTOR COULD NOT ASPIRATE FLUID THROUGH THE FIRST NEEDLE, AS IT BENT EASILY ((B)(4)). THE SECOND NEEDLE STIFFENED AND THE DOCTOR PUNCTURED THE SCOPE WHEN TAKING A SPECIMEN OF THE DUODENAL BULB."((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287915 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1