MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number	G55738
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number: k142688.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
The needle bent during a punction under high endo endoscopy.Risk of perforations.Change of needle."as per complaint form": after the 1st passage the needle was badly bent.Doctor changed for another needle for the rest of the procedure.
Additional Manufacturer Narrative
510(k) number: k142688.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).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial mdr report.After the submission of the initial report , updates were made to cook ireland¿s risk management system in accordance with (b)(4).These updates included the requirement to identify the initial probability of occurrence and the individual risk levels associated with each hazard and hazardous situation.As a result of the system updates the risk documentation has been revised.The severity associated with the hazardous situation has not changed however the identified risk levels associated with distal and proximal needle kinks on (b)(4) devices have reduced, and are now identified as low risk.This case were initially reported on the description of a distal needle kink.A serious deterioration in the state of health of the patient was not reported in this case.The initial assessment was based on the current risk at the time for those failure modes within the original risk documentation and the case was reported based on potential for harm to occur as per section 803.50 of 21 cfr 803.Fda mdr reporting is not required.Overall risk assessed as category iia (low).
Event or Problem Description
This report is being submitted to cancel the initial mdr report the needle bent during a punction under high endo endoscopy.Risk of perforations.Change of needle."as per complaint form": after the 1st passage the needle was badly bent.Doctor changed for another needle for the rest of the procedure.
Event or Problem Description
The needle bent during a punction under high endo endoscopy.Risk of perforations.Change of needle."as per complaint form": after the 1st passage the needle was badly bent.Doctor changed for another needle for the rest of the procedure.
Additional Manufacturer Narrative
510 (k) number: k142688.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.Device evaluation: the echo-hd-25-c device of c1419788 lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Additional information received and device is returning now to cirl for evaluation, a follow up mdr will be submitted to include the device evaluation once it is returned.Additional information and image was provided, complaint device involved a kink/ bend in the needle, located on the patient end.It was noted that the endoscope was in a flexed/twisted position during procedure.Complaint is confirmed based on customer testimony.Root cause: a possible root cause for the occurrence may be due to flexed/twisted position of endoscope during procedure.Complaints of this nature will continue to be monitored for potential emerging trends.Documents review: a review of qc not reveals any discrepancies that could have contributed to this complaint issue.Prior to distribution, all echo-hd-25-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 # c1419788; upon review of complaints this failure mode has not occurred previously with this lot # c1419788.The notes section of the instructions for use, ifu0077-4, 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".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.Summary: complaint is confirmed based on customer testimony.The risk associated with this complaint is risk category iii/no risk level.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.H3 other text : 510 (k) number: k142688.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.Device evaluation: the echo-hd-25-c device of c1419788 lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Additional information received and device is returning now to cirl for evaluation, a follow up mdr will be submitted to include the device evaluation once it is returned.Additional information and image was provided, complaint device involved a kink/ bend in the needle, located on the patient end.It was noted that the endoscope was in a flexed/twisted position during procedure complaint is confirmed based on customer testimony.Root cause: a possible root cause for the occurrence may be due to flexed/twisted position of endoscope during procedure.Complaints of this nature will continue to be monitored for potential emerging trends.Documents review: a review of qc not reveals any discrepancies that could have contributed to this complaint issue.Prior to distribution, all echo-hd-25-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 # c1419788; upon review of complaints this failure mode has not occurred previously with this lot # c1419788.The notes section of the instructions for use, ifu0077-4, 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".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.Summary: complaint is confirmed based on customer testimony.The risk associated with this complaint is risk category iii/no risk level.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.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7385111
• Report Number: 3001845648-2018-00148
• Device Sequence Number: 16401650
• Product Code: FCG
• UDI-Device Identifier: 00827002557383
• UDI-Public: (01)00827002557383(17)201108(10)C1419788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2018

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: 11/08/2020
• Device Model Number: G55738
• Device Catalogue Number: ECHO-HD-25-C
• Device Lot Number: C1419788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018; 03/05/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 04/26/2018; 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1