BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 16960828 · Received May 19, 2023

    Report

    Report Number
    3001845648-2023-00380
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 20, 2023
    Report Date
    January 22, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    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. 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 1 UNIT OF LOT C1980712 OF ECHO-19 WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINT FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO (B)(4). IMAGES OF THE DEVICE BEFORE SHIPPING BACK TO CIRL WERE SHARED AS FOLLOWS; - THE NEEDLE TIP BENT WHICH WAS OBSERVED AFTER OPENING THE PACKAGING - DAMAGE TO THE DISTAL END OF THE SHEATH WHICH WAS OBSERVED AFTER THE DEVICE WAS RETRACTED FROM THE PATIENT . THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6) 2023. THE LAB AND LAB ATTENDANCE CAN BE VIEWED IN THE ¿RETURNED PRODUCT ¿ NOTES¿ SECTION. SLIGHT KINK OBSERVED AT THE TIP OF THE NEEDLE. A NEEDLE KINK BELOW THE SHEATH EXTENDER WAS OBSERVED. TIP OF SHEATH EXAMINED AND OBSERVED TO BE TORN. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER C1980712 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. 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¿ AND "THE STYLET MUST BE RETRACTED (APPROXIMATELY 1CM) FROM THE LUER FITTING ON THE NEEDLE HANDLE PRIOR TO PUNCTURE". THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0101) AS THE ADDITIONAL INFORMATION RECEIVED WOULD INDICATE THAT THE NEEDLE TIP WHICH WAS OBSERVED TO BE BENT AFTER OPENING THE PACKAGING WAS STILL USED ON THE PATIENT. THERE IS ALSO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO THE CORRECT USE OF THE STYLET. AN ADDITIONAL (B)(64 WAS OPENED IN RELATION TO THE ABOVE USER ERROR ISSUES. IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TRANSPORTATION, STORAGE FACILITIES OR HANDLING OF THE PACKAGING AFTER THE DEVICE LEFT THE MANUFACTURING FACILITY WHICH MAY HAVE CAUSED THE NEEDLE TO BEND SLIGHTLY AT ITS TIP. THIS WOULD HAVE LED TO ADVANCEMENT DIFFICULTIES DURING THE FIRST PUNCTURE AND TO THE DISTAL END OF THE SHEATH GETTING DAMAGED WITH THE BENT DISTAL NEEDLE TIP RESULTING IN THE RETRACTION DIFFICULTIES AS PER Q.17 OF THE ADDITIONAL QUESTIONS. THESE RETRACTION DIFFICULTIES MAY HAVE LED TO THE KINK BELOW THE SHEATH EXTENDER RESULTING IN THE DIFFICULTY DETACHING THE DEVICE FROM THE SCOPE AS PER Q.31 OF THE STANDARD QUESTIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. 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 SIMILAR EVENTS.

    Description of Event or Problem · 0

    USER DETECTED THE NEEDLE TIP CURVED JUST OUT OF PACKAGE, AND THERE IS NEEDLE ADVANCEMENT DIFFICULTY DURING FIRST PUNCTURE, AND THE DISTAL END OF SHEATH BROKEN AFTER DEVICE RETRACTED FROM PATIENT. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.".

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A LAB EVALUATION COMPLETED ON 25-MAY-2023.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075708 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1980712

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female