MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G31518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number; k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As per cc form "while doing eus-fna, handle of eus-fna needle got disengaged from the assembly".
Additional Manufacturer Narrative
510 (k) number; k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-1-22 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-1-22 of lot number c1400534 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 c1400534.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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.The failure of sheath adjustor difficulties was concluded from the available information.A definitive root cause could not be determined from the available information.As there was no additional information shared a possible root cause is difficult to determine but could be attributed to the device potentially being used in a flexed or twisted position during the procedure.Complaint is confirmed based on the customer's 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.
Event or Problem Description
As per customer complaint form "while doing eus-fna, handle of eus-fna needle got disengaged from the assembly".
Additional Manufacturer Narrative
510 (k) number; k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As per customer complaint form "while doing eus-fna, handle of eus-fna needle got disengaged from the assembly".
Additional Manufacturer Narrative
(b)(4).Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As per cc form "while doing eus-fna, handle of eus-fna needle got disengaged from the assembly".
Additional Manufacturer Narrative
510 (k) number- k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining to section g.1 as follows: importer site contact and address: ed sutkowski cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113.Complaint device was not returned therefore a document based review will be performed.Prior to distribution, all echo-1-22 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-1-22 of lot number c1400534 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 c1400534.The notes section of the instructions for use, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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.The failure of sheath adjustor difficulties was concluded from the available information.A definitive root cause could not be determined from the available information.A possible root cause can be attributed to excessive handling.Complaint is confirmed based on the customer's 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.
Event or Problem Description
As per customer complaint form "while doing eus-fna, handle of eus-fna needle got disengaged from the assembly".Additional information was provided on 01-jul-19 as follows: for all complaints, ask: 1.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? ans: handle and got detached from sheath 2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Ans: pancreas a.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.3.Please describe the size of the intended target site.Ans: 51 x 28 mm 4.If not with the device in question, how was the procedure performed and/or finished? 5.Was the device used in a tortuous position? ans: no 6.Are images of the device or procedure available?ans: yes 7.Was it damaged in packaging before removal?ans: no 8.Was it damaged on removal from packaging?ans: no 9.Was force required to remove the device?ans: no for complaints occurring during use (once in contact with endoscope) also ask: 10.What is the endoscope manufacturer and model number that was used?ans: olympus gf- vc 240-p 11.Was the scope recently serviced / repaired?ans: no 12.Was force required on insertion of device into scope?ans: no 13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? ans: on needle retraction 14.What is the endoscope manufacturer and model number that was used with this device?ans: as above 15.Was difficulty experienced while retracting the needle?ans: yes 16.Was the needle able to be fully retracted before removing from the patient?ans: yes 17.Was gaining access to the targeted site difficult?ans: no 18.Was the endoscope in a flexed or twisted position at any time during the procedure?ans: no 19.Was needle penetration of the targeted site difficult?ans: yes 20.Was the stylet fully in place inside the needle when advancing into the targeted site?ans: no 21.Was the stylet partially removed prior to advancement of needle?ans: yes 22.How many biopsies/passes were obtained with use of this needle?ans: 1 (one) 23.Did any section of the device detach inside the patient?ans: no 24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope?ans: n/a 25.Was there difficulty or slipping experienced of the sheath extender or lock ring during use?ans: no 26.Was there difficulty in attachment / detachment of the leur to the scope?ans: no 27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? not answer.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8159199
• Report Number: 3001845648-2018-00577
• Device Sequence Number: 2287972
• Product Code: FCG
• UDI-Device Identifier: 00827002315181
• UDI-Public: (01)00827002315181(17)200914(10)C1400534
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K083330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: G31518
• Device Catalogue Number: ECHO-1-22
• Device Lot Number: C1400534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 11/15/2018; 11/15/2018; 07/01/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/10/2019; 02/07/2019; 03/07/2019; 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 39