BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 16917916 · Received May 12, 2023

    Report

    Report Number
    3001845648-2023-00353
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    March 29, 2021
    Report Date
    September 6, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #K210476. DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN INSTRUCTIONS FOR USE AND / LABEL THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101 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" AS PER THE INSTRUCTIONS FOR USE, (IFU0101) WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS WITH GASTROINTESTINAL ENDOSCOPY SUCH AS ACUTE PANCREATITIS, ALLERGIC REACTION TO MEDICATION, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, FEVER, HEMORRHAGE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0101). IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICE. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/UNDERLYING CONDITIONS, BLEEDING IS A KNOWN POTENTIAL COMPLICATION WITH A GASTROINTESTINAL ENDOSCOPY PROCEDURE. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP 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 510K #K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-SEP-23.

    Description of Event or Problem · 0

    DELCONTE 2022 - DOES PROCORE FINE-NEEDLE BIOPSY REALLY IMPROVE THE CLINICAL OUTCOME OF ENDOSCOPIC ULTRASOUND-GUIDED SAMPLING OF PANCREATIC MASSES? MATERIALS AND METHODS: ALL THE INVESTIGATIONS WERE PERFORMED BY A SINGLE ENDOSCOPIST. IN ALL PATIENTS, STANDARDIZED CONSCIOUS SEDATION OR DEEP SEDATION WITH ANESTHESIOLOGIC ASSISTANCE WAS PERFORMED. A CURVILINEAR ECHOENDOSCOPE (GF-UC180T; OLYMPUS MEDICAL SYSTEMS, EUROPE) WAS USED FOR ALL EXAMINATIONS. A FANNING TECHNIQUE WITH SLOW-PULL WAS USED, WITH SUCTION ROUTINELY APPLIED USING A SYRINGE BOTTLE. DURING THE PERIOD AUGUST 2012¿JANUARY 2015, ALL PROCEDURES WERE PERFORMED WITH STANDARD NEEDLES, WHEREAS FROM FEBRUARY 2015 UNTIL SEPTEMBER 2018, PRO-CORE NEEDLES WERE UTILIZED. ADVERSE EVENTS REQUIRING ADMISSION WERE REPORTED IN 3 PATIENTS (0.9%) AND WERE ALL DUE TO BLEEDING. TWELVE PATIENTS (3.1%) EXPERIENCED MILD INTRA LUMINAL BLEEDING THAT WAS MANAGED CONSERVATIVELY. THIS FILE WILL CAPTURE THE 12 CASES OF MINOR BLEEDING IN FNA GROUP, COUNTRY OF OCCURRENCE ITALY. [MAJOR BLEEDING IN 3 PATIENTS REQUIRING HOSPITALIZATION (SEVERITY = 4); MINOR BLEEDING IN 12 PATIENTS MANAGED CONSERVATIVELY (SEVERITY = 3)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032081 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention