BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 10988112 · Received December 10, 2020

    Report

    Report Number
    3001845648-2020-00935
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 17, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002347851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. 1 UNIT OF LOT C1704704 OF ECHO-HD-3-20-C WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 17 DEC 2020. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-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 A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C1704704 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1704704. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077-4, 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". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR (IFU0077-4). A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO HARD LESION AS INDICATED IN THE COMPLAINT DESCRIPTION CAUSING THE NEEDLE TIP TO BREAK. ITS MOST LIKELY THE NEEDLE SLIP FELT BY THE USER WAS DUE TO THE BREAKING OF THE NEEDLE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE BROKEN NEEDLE TIP WAS FOUND IN THE STOMACH AND RECOVERED BY ENDOSCOPY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED AND EVALUATED ON THE 17-DEC-2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THIS NEW INFORMATION WITHIN SECTION D & H. THE INVESTIGATION WAS ALSO CONCLUDED ON THE 05-JAN-2021, THE INVESTIGATION CONCLUSIONS WILL ALSO BE INCLUDED IN THIS REPORT WITHIN SECTION H.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K142688. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    ATTEMPTED PUNCTURE OF A PANCREATIC LESION BY TRANS ROUTE GASTRIC,WITHOUT EXCESSIVE BIASING AT THE ECHOENDOSCOPE. FAILURE PUNCTURE, THE NEEDLE SEEMS TO "SLIP". CHECKING THE NEEDLE AFTER PROCEDURE FINDS A "CUT" NEEDLE AT THE FENESTRATION, MISSING THE DISTAL END, WHICH IS FOUND IN THE STOMACH AND RECOVERED BY ENDOSCOPY. "AS PER CC FORM": SURGEON WAS TRYING TO PUNCTION THE PANCREAS BY TRANSGASTRIC WAY, SO GOOD POSITION, ENDOSCOPE NOT BENT, VERY LIGHT USE OF ELEVATOR BUT LESION WAS HARD AND THE NEEDLE DID NOT WANT TO GET INTO THE LESION, THE NEEDLE WAS SLIPPING ON SITE TO PUNCTION. SURGEON HAS DECIDED THEN TO CHANGE THE NEEDLE AND REMOVED THE ECHO AND SHE REALISED AT NEEDLE CHECKING THAT THE DISTAL PART WAS MISSING. NEEDLE WAS BROKEN AT DISTAL TIP WHERE THE NEEDLE HAS THE WINDOW. THE BROKEN TIP WAS FOUND IN THE STOMACH OF THE PATIENT. HOPEFULLY THE BROKEN PART WAS REMOVED AND PATIENT IS OK CUSTOMER DECIDED TO USE AN ACQUIRE BOSTON NEEDLE AND THE PUNCTION WAS DONE EASILY WITH NO ISSUE TRANSLATION: ATTEMPT TO PUNCTURE A PANCREATIC LESION BY TRANS GASTRIC ROUTE, WITHOUT EXCESSIVE BENDING AT THE LEVEL OF THE ECHOENDOSCOPE. PUNCTURE FAILURE, THE NEEDLE SEEMS TO "SLIDE" OVER THE LESION, WITHOUT PENETRATING IT. DECISION TO CHANGE THE NEEDLE. CHECKING THE NEEDLE AFTER THE PROCEDURE FINDS A "CUT" NEEDLE AT THE WINDOWS. THE DISTAL END IS MISSING, WHICH IS FOUND IN THE STOMACH AND RECOVERED BY ENDOSCOPY. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. DISTAL TIP ON THE NEEDLE WAS BROKEN AND STAYED IN THE STOMACH. SURGEON SUCCEEDED TO REMOVE THE BROKEN PART AND PATIENT IS OK THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. SURGEON HAD TO RESTART THE PROCEDURE OF PUNCTION BUT SHE USED AN ACQUIRE BOSTON NEEDLE AND THE PUNCTION WAS DONE EASILY WITH NO ISSUE (AS SURGEON TOLD ME) ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). PANCREAS BUT POSITION WAS TRANSGASTRIC A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S ETC. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE MIDDLE OF PANCREAS. IF NOT WITH THE DEVICE IN QUESTION, HOW 1. IF THE WAS THE PROCEDURE PERFORMED AND/OR FINISHED? FINISHED OK WITH ACQUIRE BOSTON NEEDLE. WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO. WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS UCT 180. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO. WHEN WAS THE ISSUED NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? AT PUNCTION. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? NO. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO. WAS IT POSSIBLE TO FULLY RETRACT BEFORE REMOVING THE NEEDLE FROM THE PATIENT? YES. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? NO. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? NO. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING INTO THE TARGET SITE? NO. HOW MANY SAMPLES WERE OBTAINED WITH THIS NEEDLE? 0. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? NOT KNOWN. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE OF THE LEUR LOCK TO THE SCOPE? NO BROKEN AT CORE TRAP. IF THE DEVICE IS A PROCORE, IS THE KINK LOCATED DISTALLY AT THE NOTCH / CORE TRAP? IS THE PATIENT KNOWN TO BE COVID-19 POSITIVE? NOT COMMUNICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448961 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1704704 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention