BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 10122551 · Received June 5, 2020

    Report

    Report Number
    3001845648-2020-00341
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    December 16, 2019
    Report Date
    June 17, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 K # - K092359. DEVICE EVALUATION: 1 UNIT OF UNKNOWN LOT NUMBER OF ECHO HD 19 A WAS RETURNED NOT 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 PR 288393. DEVICE WITH RPN ECHO-HD-19-A WAS RETURNED IN FEBRUARY 2020, LAB EVALUATION CONFIRMED DEVICE TO BE BROKEN IN 4 PLACES, 3 PROXIMAL BREAKAGES AND 1 DISTAL BREAKAGE. THIS DEVICE WAS BELIEVED TO BE RELATED TO (B)(4) (REF EMDR # 3001845648-2020-00047) AS IT WAS BELIEVED TO BE CORRECT DEVICE AT THE TIME, HOWEVER THIS IS NOW KNOWN TO BE WRONG AS ACTUAL COMPLAINT DEVICE FOR (B)(4) (REF EMDR # 3001845648-2020-00047) WAS RECEIVED AND EVALUATED IN THE LAB ON 07 MAY 2020. DETAILS OF COMPLAINT ISSUE IN RELATION TO DEVICE RETURNED IN FEBRUARY 2020 HAVE BEEN REQUESTED AND RECEIVED FROM SALES REP AND THIS FILE NOW OPENED IN RELATION TO THAT DEVICE LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 19 FEB 2020. THE NEEDLE WAS OBSERVED TO BE BROKEN IN FOUR PLACES (1 DISTAL AND 3 PROXIMAL) THE NEEDLE HANDLE WAS ALSO OBSERVED TO BE BROKEN. ALTHOUGH NOT STATED IN THE LAB EVALUATION NOTES A PROXIMAL KINK WAS ALSO OBSERVED. CLARIFICATION WAS ALSO REQUESTED AS FOLLOWS; "CAN YOU ASK IF THE DEFECTIVE ELEVATOR (ERECTOR) CAUSED THE NEEDLE TO BREAK IN THE FIRST PLACE AND THEN ALL FOLLOWING FAILURES WERE AS A RESULT OF THE EXCESSIVE FORCE APPLIED TO REMOVE THE NEEDLE?" REPLY WAS RECEIVED AS FOLLOWS; "THAT IS INDEED WHAT HAPPENED. THE FAULTY ERECTOR, ELEVATOR WAS DEFECTIVE, HE HAD NO CHOICE BUT TO FORCE IT OUT." CLARIFICATION WAS REQUESTED FROM THE PRODUCT MANAGER AS FOLLOWS; "DO YOU KNOW WHAT PART OF THE SCOPE IS THE ERECTOR" REPLY WAS RECEIVED AS FOLLOWS; "I AM PRETTY SURE IT¿S A TYPO AND THE MEAN ELEVATOR" CLARIFICATION WAS REQUESTED AS FOLLOWS; MANUFACTURER INVESTIGATOR IS ASKING IN RELATION TO THE DEICE WHICH WAS RETUNED IN FEBRUARY (THIS REPORT), THE REP CONFIRMED AT THAT TIME THAT THE ROOT CAUSE FOR THE ISSUE WITH THAT DEVICE WAS A FAULTY ELEVATOR (ERECTOR). AM I TO ASSUME THAT THIS EXPLANATION IS NOT RELEVANT FOR THE DEVICE WHICH WAS RETURNED TO CIRL AND EVALUATED IN THE LAB LAST WEEK ((B)(4) REF EMDR # 3001845648-2020-00047)? THE DEVICE EVALUATED IN THE LAB LAST WEEK HAD A DISTAL NEEDLE BREAK AND DISTAL SHEATH DAMAGE (AS WELL AS A PROXIMAL KINK BELOW THE SHEATH EXTENDER). REPLY WAS RECEIVED AS FOLLOWS; IN FACT, THE DOCTOR HAD THE SAME PROBLEM ON THE SAME DAY. HE DAMAGED BOTH NEEDLES IN THE SAME WAY. IT WAS A PROBLEM WITH THE ENDOSCOPE¿S ERECTOR. IT WASN¿T THE NEEDLES THAT WERE THE PROBLEM, IT WAS THE FAULTY ENDOSCOPE. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO HD 19 A 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 THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS PART OF THE INVESTIGATION. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0050 2, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "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 USE (B)(4). IMAGE REVIEW N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO A DEFECTIVE ELEVATOR OF THE SCOPE WHICH CAUSED THE NEEDLE TO BREAK AND THEN ALL FOLLOWING FAILURES WERE AS A RESULT OF THE EXCESSIVE FORCE APPLIED TO REMOVE THE NEEDLE. THE KINK AND BREAKAGES ARE ALL AS A RESULT OF THE ELEVATOR ISSUE AND THE FORCE APPLIED TO THE DEVICE DURING THE PROCEDURE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 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.

    Description of Event or Problem · 0

    THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE, WE WERE NOT AWARE THAT THE DEVICE FOR THIS COMPLAINT WAS ACTUALLY RELATED TO THIS CURRENT COMPLAINT UNTIL 07-MAY-2020 AS WHEN WE ORIGINALLY RECEIVED IT IN FEBRUARY 2020 IT WAS INCORRECTLY RELATED TO (B)(4) (REF EMDR # 3001845648-2020-00047). THIS ERROR WAS REALISED ON 07-MAY-2020 AND FOR THIS REASON WE ONLY BECAME AWARE OF THIS COMPLAINT ON 07-MAY-2020. 510 K # - K092359. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    DEVICE WITH RPN ECHO-HD-19-A WAS RETURNED ON 19TH FEBRUARY 2020, LAB EVALUATION CONFIRMED DEVICE TO BE BROKEN IN 4 PLACES, 3 PROXIMAL BREAKAGES AND 1 DISTAL BREAKAGE. INITIALLY THIS DEVICE WAS BELIEVED TO BE RELATED TO COMPLAINT (B)(4) (REF EMDR # 3001845648-2020-00047), HOWEVER THIS IS NOW KNOWN TO BE WRONG AS ACTUAL COMPLAINT DEVICE FOR (B)(4) (REF EMDR # 3001845648-2020-00047) WAS RECEIVED ON 07-MAY-2020. PLEASE NOTE, WE WERE NOT AWARE THAT THE DEVICE FOR THIS COMPLAINT WAS ACTUALLY RELATED TO THIS CURRENT COMPLAINT UNTIL 07 -MAY-2020 AS WHEN WE ORIGINALLY RECEIVED IT IN FEBRUARY 2020 IT WAS INCORRECTLY RELATED TO (B)(4) (REF EMDR # 3001845648-2020-00047). THIS ERROR WAS REALISED ON 07-MAY-2020 AND FOR THIS REASON WE ONLY BECAME AWARE OF THIS COMPLAINT ON 07-MAY-2020. ADDITIONAL INFORMATION FOR THIS CURRENT COMPLAINT WAS RECEIVED FROM THE REP ON THE FOLLOWING DATES: AS PER INFORMATION RECEIVED ON 14-MAY-2020: IN FACT, THE DOCTOR HAD THE SAME PROBLEM ON THE SAME DAY. HE DAMAGED BOTH NEEDLES IN THE SAME WAY. IT WAS A PROBLEM WITH THE ENDOSCOPE¿S ERECTOR. IT WASN¿T THE NEEDLES THAT WERE THE PROBLEM, IT WAS THE FAULTY ENDOSCOPE. (PLEASE NOTE, OTHER NEEDLE BEING REFERRED TO IS THAT IN (B)(4) REF EMDR # 3001845648-2020-00047). AS PER INFORMATION RECEIVED ON 26-MAY-2020: HE NEEDLE BROKE OUTSIDE THE PATIENT AND NO DEBRIS REMAINED IN THE WORKING CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586498 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1