BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 15282136 · Received August 24, 2022

    Report

    Report Number
    3001845648-2022-00574
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    December 9, 2014
    Report Date
    May 2, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 ECHO-19 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT FILE WAS 1 OUT OF 4 OPENED FROM THE SOH ET AL 2014 LITERATURE PAPER IN RELATION TO THE OFF LABEL USE OF 1ECHO-19 DEVICE OF UNKNOWN LOT NUMBER. REGION. PR 372838 (EMDR REF. - 3001845648-2022-00566) : SOH ET AL 2014 ¿ 6 CASES OF OFF-LABEL USAGE (ECHO-19) PR 372839 (EMDR REF. - 3001845648-2022-00567) : SOH ET AL 2014 ¿ 10 CASES OF OFF-LABEL USAGE (ECHO-1-22 OR ECHO-3-22) PR 372840 (EMDR REF. - 3001845648-2022-00573) : SOH ET AL 2014 ¿ 7 CASES OF OFF-LABEL USAGE AND 1 CASE OF PAIN/ DISCOMFORT (ECHO-HD-22-C) PR (B)(4) (EMDR REF. - 3001845648-2022-00574) : SOH ET AL 2014 ¿ 1 CASE OF OFF-LABEL USAGE AND CASE OF FEVER (ECHO-19) LAB EVALUATION N/A DOCUMENT REVIEW INCLUDING IFU REVIEW PRIOR TO DISTRIBUTION, ALL ECHO-19 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 NUMBERS ARE UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE 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 EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THERE WAS 1CASES OF THE NEEDLE USE IN THE "RECTAL AND PERIRECTAL" WHICH WOULD BE CONSIDERED OFF LABEL USE. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IMAGE REVIEW N/A ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD BE ATTRIBUTED TO OFF-LABEL USE AS THERE WAS 6 CASES OF THE NEEDLE USE IN THE "RECTAL AND PERIRECTAL" WHICH WOULD BE CONSIDERED OFF LABEL USE. AS PER IFU "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE." SUMMARY COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED A FEVER COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SOH ET AL 2014, THE CLINICAL USEFULNESS OF ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION AND BIOPSY FOR RECTAL AND PERIRECTAL LESIONS. EUS-FNA WAS PERFORMED USING 19- [PR 372838: SOH ET AL 2014 ¿ 6 CASES OF OFF-LABEL USAGE (ECHO-19)] OR 22-GAUGE [PR 372839: SOH ET AL 2014 ¿ 10 CASES OF OFF-LABEL USAGE (ECHO-1-22 OR ECHO-3-22)] DISPOSABLE NEEDLES (ECHOTIP ULTRA; COOK MEDICAL INC., BLOOMINGTON, IN, USA). AFTER THE FNA NEEDLE WAS ADVANCED THROUGH THE INSTRUMENT CHANNEL OF THE LINEAR-ARRAY ECHOENDOSCOPE, THE INTERNAL STYLET WAS REMOVED AND THE NEEDLE WAS RECIPROCATED BACK AND FORTH WITHIN THE LESION. THE NEEDLE WAS WITHDRAWN FROM THE SCOPE AND AIR WAS INFUSED WITH A SYRINGE TO EXTRACT THE TISSUE MATERIAL ONTO A SLIDE. AFTER CONFIRMING WHETHER THE TISSUE MATERIAL WAS ADEQUATE, THE NEEDLE WAS AGAIN PASSED THROUGH THE LESION. EUS-FNB WAS PERFORMED USING TWO DIFFERENT METHODS: TRUCUT NEEDLE BIOPSY [NON-COOK IRELAND PRODUCT] OR PROCORE NEEDLE BIOPSY. AN EUS TRUCUT USING A 19-GAUGE NEEDLE DEVICE (QUICK-CORE; COOK MEDICAL INC.) FITTED WITH A SPRING-LOADED MECHANISM WAS THE BASIC PRINCIPLE UNDERLYING THE PROCEDURE. AFTER THE NEEDLE WAS PLACED IN THE LESION, THE SPECIMEN TRAY WAS ADVANCED INTO THE LESION USING A SPRING-LOADED HANDLE TO OBTAIN CORE TISSUE. AN EUS-PROCORE NEEDLE BIOPSY WAS NEWLY INTRODUCED AS A PROCEDURE IN 2012. THUS, EUS-FNB WITH PROCORE NEEDLE WAS NOT EXAMINED IN OUR PREVIOUS REPORT AND WE NEWLY ANALYZED THE PERFORMANCE OF EUS-FNB WITH PROCORE NEEDLE IN THE PRESENT STUDY. A FINE NEEDLE BIOPSY WAS ALSO PERFORMED USING A 22-GAUGE NEEDLE DEVICE (ECHOTIP PRO-CORE-22; COOK MEDICAL INC.) WITH A REVERSE BEVEL DESIGN [PR 372840: SOH ET AL 2014 ¿ 7 CASES OF OFF-LABEL USAGE AND 1 CASE OF PAIN/ DISCOMFORT (ECHO-HD-22-C)]. THE PROCEDURE WITH A PROCORE NEEDLE BIOPSY WAS SIMILAR TO THE EUS-FNA TECHNIQUE USING RETROGRADE NEEDLE MOTION TO ACQUIRE SHEARING TISSUES; HOWEVER, THE DIFFERENCE WAS THAT THE NEEDLE FOR THE PROCORE BIOPSY WAS EQUIPPED WITH A 10-ML SUCTION SYRINGE AFTER REMOVING THE STYLET TO EXTRACT CORE TISSUES. COMPLICATIONS: TWO COMPLICATIONS OF MILD FEVER AND ASYMPTOMATIC PNEUMOPERITONEUM WERE NOTED IMMEDIATELY AFTER THE PROCEDURES. NO PATIENT EXPERIENCED ANY SEVERE COMPLICATION. -IN 1 PATIENT (NO. 11), FEVER OCCURRED 1 DAY AFTER EUS-FNA/B. ANTIBIOTICS WERE INFUSED INTRAVENOUSLY AND SHE WAS UNEVENTFULLY DISCHARGED 4 DAYS AFTER EUS-FNA/B. PROPHYLACTIC ANTIBIOTICS HAD NOT BEEN ADMINISTERED BEFORE HER EUS-FNA/B PROCEDURE. [PR 372842: SOH ET AL 2014 ¿ 1 CASE OF OFF-LABEL USAGE AND CASE OF FEVER (ECHO-19)] -ANOTHER PATIENT (NO. 14) WAS DIAGNOSED WITH A PNEUMOPERITONEUM RADIOLOGICALLY AFTER EUS-FNB. HOWEVER, HE DID NOT SHOW ANY SYMPTOMS ASSOCIATED WITH PERITONITIS AND WAS DISCHARGED TWO DAYS LATER. A TOTAL OF 22 PATIENTS (73%) RECEIVED PROPHYLACTIC ANTIBIOTICS PRIOR TO THEIR EUS PROCEDURE. [PR 372840: SOH ET AL 2014 ¿ 7 CASES OF OFF-LABEL USAGE AND 1 CASE OF PAIN/ DISCOMFORT (ECHO-HD-22-C)] THIS FILE WILL CAPTURE THE 1 CASE OF OFF-LABEL USAGE USING ECHO-HD-22-C ON RECTAL AND PERIRECTAL LESIONS AND CASE OF FEVER. PATIENT NO. 11, FEVER OCCURRED 1 DAY AFTER EUS-FNA/B. ANTIBIOTICS WERE INFUSED INTRAVENOUSLY AND SHE WAS UNEVENTFULLY DISCHARGED 4 DAYS AFTER EUS-FNA/B. PROPHYLACTIC ANTIBIOTICS HAD NOT BEEN ADMINISTERED BEFORE HER EUS-FNA/B PROCEDURE. THE MEDIAN AGE OF THE 30 PATIENTS WHO UNDERWENT EUS-FNA/B WAS 56 YEARS (RANGE, 33-81 YEARS), AND 18 PATIENTS WERE MALE.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 02-MAY-2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827991 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male