BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 16917983 · Received May 12, 2023

    Report

    Report Number
    3001845648-2023-00362
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    November 30, 2020
    Report Date
    May 25, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. DEVICE EVALUATION: THE ECHO-HD-22-C DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. TONG 2021 - COMPARISON BETWEEN MODIFIED WET SUCTION AND DRY SUCTION TECHNIQUE FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY IN PANCREATIC SOLID LESION. COMPLAINT FILES PR 396319, PR (B)(4), PR (B)(4), AND PR (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. PR (B)(4) - TONG 2021 ¿ 1 CASE OF MILD ABDOMINAL PAIN. PR (B)(4) - TONG 2021 ¿ 50 CASES OF OFF-LABEL USAGE OF MWEST USING PROCORE NEEDLE (EMDR NUMBER 3001845648-2023-00363). PR (B)(4) - TONG 2021 ¿ 1 CASE OF DISTAL NEEDLE KINK. PR (B)(4)- TONG 2021 ¿ 50 CASES OF USER ERROR OF STYLET REMOVED BEFORE NEEDLE ADVANCEMENT IN MWEST - WHICH THIS FILE WILL INVESTIGATE. (EMDR NUMBER 3001845648-2023-00362). DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-C 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 A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. AS PER THE INSTRUCTIONS FOR USE, (IFU0077) WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE" THE PRECAUTIONS SECTION INSTRUCTS: ¿ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE.¿ THERE IS EVIDENCE TO SUGGEST FROM THE LITERATURE ARTICLE THAT THE RELEVANT USERS DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE USE OF THE STYLET (IFU0077). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR AS THE STYLET SHOULD BE FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 25-MAY-2023.

    Description of Event or Problem · 0

    TONG 2021 - COMPARISON BETWEEN MODIFIED WET SUCTION AND DRY SUCTION TECHNIQUE FOR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE BIOPSY IN PANCREATIC SOLID LESIONS. PATIENTS WERE DIVIDED INTO GROUP A AND GROUP B ACCORDING TO A PREDETERMINED RANDOMIZATION SCHEDULE. FOR GROUP A, THE PASS SEQUENCE WAS DST, MWEST, DST, AND MWEST. FOR GROUP B, THE SEQUENCE WAS MWEST, DST, MWEST, AND DST. INTERVENTION: IN THE MWEST, BEFORE THE NEEDLE WAS INSERTED INTO THE BIOPSY CHANNEL, THE STYLET WAS REMOVED, AND THE NEEDLE WAS FLUSHED WITH SALINE SOLUTION UNTIL THE FLUID DRIPPED OUT OF THE NEEDLE TIP. THE AIR COLUMN WAS REPLACED WITH THE FLUID. A 10-ML SYRINGE WAS PREFILLED WITH 2 ML OF SALINE SOLUTION, AND THE VALVE WAS CLOSED. THE SYRINGE WAS LOADED TO THE 5-ML POSITION (I.E. A 3-ML VACUUM) AND THEN ATTACHED TO THE PROXIMAL PORT AND USED FOR BIOPSY AFTER INSERTING INTO THE BIOPSY CHANNEL AND PUNCTURING THE LESION (FIG. 1). IN THE STANDARD SUCTION TECHNIQUE (DST), AFTER THE NEEDLE WAS INSERTED INTO THE BIOPSY CHANNEL, AND THE LESIONS WERE PUNCTURED, THE STYLET WAS REMOVED. A SYRINGE WITH 5-ML PRE-VACUUM WAS AT-TACHED IN A ¿LOCKED¿ POSITION (I.E. A 5-ML VACUUM) TO THE PROXIMAL PORT OF THE NEEDLE AND LATER USED FOR BIOPSY. ALL EUS-FNB PROCEDURES WERE PERFORMED USING A 22-GAUGE FNB NEEDLE (ECHOTIP PROCORE; COOK MEDICAL, LIMERICK, IRELAND), WHICH IS KNOWN AS A CORE NEEDLE. AFTER ENDOSCOPIC ULTRASOUND DEMONSTRATED NO INTERVENING BLOOD VESSELS, NEEDLES WERE INTRODUCED INTO THE LESIONS USING A TRANSGASTRIC OR TRANSDUODENAL APPROACH. THEN, THE VALVE WAS OPENED, AND THE NEEDLE WAS MOVED BACK AND FORTH WITHIN THE LESION 20 TO 30 TIMES TO OBTAIN THE SPECIMEN. THEN, THE NEEDLE WAS WITHDRAWN. IN MWEST, FLUIDS IN THE NEEDLE WERE OBSERVED TO BE MOVING INTO THE SUCTION SYRINGE. FOUR PASSES WERE PERFORMED ON EACH SOLID LESION, WITH TWO TECHNIQUES ALTERNATING ACCORDING TO THE RANDOM GROUP ASSIGNMENT. THIS FILE WILL CAPTURE THE 50 CASES OF USER ERROR OF REMOVING THE STYLET BEFORE THE NEEDLE WAS INSERTED INTO THE BIOPSY CHANNEL IN MWEST. NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185221 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male