BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 19227624 · Received May 2, 2024

    Report

    Report Number
    3001845648-2024-00198
    Event Type
    Injury
    Date Received
    May 2, 2024
    Report Date
    November 1, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "OP445 FEASIBILITY AND COMPLICATIONS RATE OF NEEDLE BASED CONFOCAL LASER ENDOMICROSCOPY (NCLE) IN PANCREATIC CYSTS : PRELIMINARY RESULTS OF A MULTICENTER PROSPECTIVE STUDY." THIS FILE IS ASSOCIATED WITH THE FOLLOWING COMPLAINT (B)(4). (B)(4) CAPTURES 28 CASES OF ABNORMAL USE. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL: THE INSTRUCTIONS FOR USE (IFU0101), WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER THAT "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE" AND IN THE PRECAUTIONS SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0101). THE USER IS ADVISED OF THE FOLLOWING POTENTIAL ADVERSE EVENTS IN THE IFU, (IFU0101) "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY: ACUTE PANCREATITIS, ALLERGIC REACTION TO MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, PAIN/DISCOMFORT, PERFORATION, PERITONITIS, RESPIRATORY DEPRESSION OR ARREST, TUMOR SEEDING (THROUGH THE NEEDLE TRACT). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, THE ECHO-19 DEVICE WAS USED IN A NEEDLE-BASED CONFOCAL LASER ENDOMICROSCOPY DURING AN ENDOSCOPIC ULTRASOUND FINE NEEDLE ASPIRATION WHICH WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0101) STATES "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE" AND IN THE PRECAUTIONS SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ IT ALSO INFORMS THE USER THAT HEMORRHAGE AND ACUTE PANCREATITIS IS A KNOWN POTENTIAL COMPLICATION. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "OP445 FEASIBILITY AND COMPLICATIONS RATE OF NEEDLE BASED CONFOCAL LASER ENDOMICROSCOPY (NCLE) IN PANCREATIC CYSTS : PRELIMINARY RESULTS OF A MULTICENTER PROSPECTIVE STUDY." CONFIRMED QUANTITY,03 DEVICES WERE CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENTS EXPERIENCED MINOR ACUTE PANCREATITIS AND INTRACYSTIC BLEEDING DUE TO THIS OCCURRENCE. AS PER THE INSTRUCTIONS FOR USE, HEMORRHAGE AND ACUTE PANCREATITIS IS A KNOWN POTENTIAL COMPLICATION. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.

    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

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 01-NOV-2024.

    Description of Event or Problem · 0

    NAPOLEON OP445 (PAGE 157) - FEASIBILITY AND COMPLICATIONS RATE OF NEEDLE BASED CONFOCAL LASER ENDOMICROSCOPY (NCLE) IN PANCREATIC CYSTS : PRELIMINARY RESULTS OF A MULTICENTER PROSPECTIVE STUDY FOLLOWING EUS EXAMINATION, THE AQ-FLEX MINIPROBE WAS INTRODUCED IN A 19G NEEDLE AND REAL-TIME VIDEO OF THE WALL WAS RECORDED. PROCEDURES WERE REALIZED WITH A COOK NEEDLE (17% OF THE CASES) OR A BOSTON FLEX (83% OF THE CASES). A PROPHYLACTIC ANTIBIOTIC THERAPY WAS SYSTEMATICALLY GIVEN BEFORE EACH PROCEDURE. CAUSES OF TECHNICAL ISSUES AND COMPLICATIONS RATE WERE PROSPECTIVELY RECORDED. NAPOLEON OP445 - THREE MINOR ACUTE PANCREATITIS (1, 6%) WERE REPORTED (48H HOSPITALIZATION). THERE WAS INTRACYSTIC BLEEDING WITHOUT ANY EXTRAVASATION IN 10% OF THE CASES, WITHOUT ANY CLINICAL CONSEQUENCE PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY. AS PER CLINICAL INPUT: MILD PANCREATITIS S=3 SELF-LIMITING BLEEDING S=3 PATIENT/EVENT INFO - NOTES: BETWEEN JUNE 2012 AND MARCH 2014, 182 PATIENTS HAVE BEEN INCLUDED, IN FOUR FRENCH CENTERS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438284 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown