MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G34281
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) number: k160229.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 report will be submitted to include the investigation conclusions.
Event or Problem Description
The needle was perforating the working channel of olympus endoscope.
Additional Manufacturer Narrative
510(k) number: k160229.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).Device evaluation the echo-hd-22-ebus-o-c device of lot number c1464880 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows; 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))? -patient end 2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).-lung a.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.-7 and 11 right 3.Please describe the size of the intended target site.-n.A.4.If not with the device in question, how was the procedure performed and/or finished? -olympus needle 5.Was the device used in a tortuous position? -n.A.6.Are images of the device or procedure available? -unfortunately not 7.Was it damaged in packaging before removal? -no 8.Was it damaged on removal from packaging? - no 9.Was force required to remove the device? -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? -see complaint form 11.Was the scope recently serviced / repaired? -totally new endoscope 12.Was force required on insertion of device into scope? -no 13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? -n.A 14.What is the endoscope manufacturer and model number that was used with this device? -see compl.Form 15.Was difficulty experienced while retracting the needle? - no 16.Was the needle able to be fully retracted before removing from the patient? -n.A.17.Was gaining access to the targeted site difficult? -n.A 18.Was the endoscope in a flexed or twisted position at any time during the procedure? - n.A.19.Was needle penetration of the targeted site difficult? -n.A.20.Was the stylet fully in place inside the needle when advancing into the targeted site? -n.A.21.Was the stylet partially removed prior to advancement of needle? -n.A 22.How many biopsies/passes were obtained with use of this needle? -n.A 23.Did any section of the device detach inside the patient? -no 24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? -n.A.25.Was there difficulty or slipping experienced of the sheath extender or lock ring during use? - n.A.26.Was there difficulty in attachment / detachment of the leur to the scope? -na.A 27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? -no, kink is above core trap the device related to this occurrence underwent a laboratory evaluation on the 25 july 2018.Slight proximal needle kink noted, does not impact functionality of sheath adjuster movement.Slight proximal needle kink possibly due to re-packaging for transport returns.Stylet partially inserted on return, difficult to remove.Force required to remove.Could not re - insert stylet when removed, possibly attributed to biological matter.Syringe was not returned.Stylet difficulties i.E.Difficult to remove.However based on defect section, this was attributed to excess biological matter noted.Distal kink reported in additional information is normal curvature post procedure being performed.Needle advances and retracts without issue.No functional issue identified in the laboratory that would lead to complaint description.Complaint is confirmed based on customer testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However a possible root cause for the occurrence may be due to the device becoming bent/kinked after hitting a hard lesion or the tracheal rings, thereafter causing needle perforating.Document review components from external suppliers, are subject to incoming inspection in cirl.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-hd-22-ebus-0-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.There is no evidence to suggest that this issue affects the entire lot # c1464880 ; upon review of complaints this failure mode has not occurred previously with this lot # c1464880.A review of the manufacturing records for echo-hd-22-ebus-o-c device of lot number c1464880 did not reveal any discrepancies that could have contributed to this complaint issue.An nc was noted on the work order, however this was subsequently re-worked and would not have attributed to this complaint issue.Ifu review: it may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any 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.Summary complaint is confirmed based on customer testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Additional information was requested to elaborate the file description and needle retraction issues.Complaint file will be updated accordingly once this information becomes available.Additional information received 'the needle was perforating the working channel of olympus endoscope'.The risk associated with the complaint is risk category iii- no risk.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
This follow up mdr is being submitted to correct the mdr reference number on the previous follow up.The previous follow up was sent with the reference number 3001845648-2018-00347 however the correct reference number is 3001845648-2018-00346.The needle was perforrating the working channel of olympus endoscope.
Event or Problem Description
Doctor removed the stone from the cbd.But stone remained in cystic duct.He was concerned that the stone of the cystic duct would come down to the bile duct, blocking the way.So he wanted to insert zso-7-5 into the cbd.While the nurse tried to insert the guide wire into the stent, pigtail of stnet was folded.So guide wrie could not pass the stnet.The new zso-7-5 was used for this case.
Additional Manufacturer Narrative
510(k) number: k851962.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).Device evaluation: 1 x zso-7-5 of lot # c1454165 was returned to cirl for evaluation.A lab evaluation was held on 30 july 2018.During the lab evaluation an indentation was noted at sideport 2.Slight indentation noted at 5th sideport was found at the second porthole tapered end.A 0.035mm wire guide would not pass through stent.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However, a possible cause of this complaint is that the kink occurred when straightening the stent.A precaution included in instructions for use states, "care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent." the complaint is confirmed as the failure was verified in the laboratory and the stent was found to be kinked.Documents review: a review of the manufacturing records for the device of lot # c1454165 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1454165; upon review of complaints this failure mode has not occurred previously with this lot # c1454165.Prd/fqc/pkg review: prior to distribution, all devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Inspections include; 'inspect for debris in or on product, kinks'.'100% inspection on all stents for kinks' and a 'check that the appropriate size wire guide moves smoothly and freely when inserted into both ends of the stent'.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Ifu review: it may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.According to the instructions for use, the user is advised of the following: ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent".Summary: the complaint is confirmed as the failure was verified in the laboratory and the stent was found to be kinked.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7725799
• Report Number: 3001845648-2018-00346
• Device Sequence Number: 16392771
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)210320(10)C1464880
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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: 03/20/2021
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1464880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 07/04/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/24/2018; 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR