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

Model Number	G34281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
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.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on 07 dec 2018.The needle was found to be broken distally.The complaint detailed that the needle hadn't been retrieved so information was requested to check if the needle was now retrieved and if there had been any adverse effects on the patient.To date this information is not known.It was also noted that the scope used was one different to that detailed in the ifu.A new pr was requested to be opened for this extra failure mode.Document review prior to distribution, all echo-hd-22-ebus-o-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-22-ebus-o-c of lot number c1543956 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 c1543956.Ifu review the notes section of the instructions for use, ifu0109-5 which accompanies this device instructs the user to; "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 evidence to suggest that the customer did not follow the instructions for use (ifu0109-5) in relation to the type of scope used.As a result a new pr has been requested to be opened.Root cause review the failure of needle broken was observed in the laboratory.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 or scope used in a flexed position as indicated in the additional information.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.
Event or Problem Description
During procedure the tip broke off and could not be retrieved as of yet."as per complaint form": during the procedure the needle tip broke off and could not be retrieved as of yet.
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.This follow up report is being submitted based on the receipt of additional information regarding the potential root cause of this complaint.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on 07 dec 2018.The needle was found to be broken distally.The complaint detailed that the needle hadn't been retrieved so information was requested to check if the needle was not retrieved and if there had been any adverse effects on the patient.To date this information is not known.It was also noted that the scope used was one different to that detailed in the ifu.Document review: prior to distribution, all echo-hd-22-ebus-o-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-22-ebus-o-c of lot number c1543956 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 c1543956.Ifu review: the notes section of the instructions for use, ifu0109-5 which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, "this device is intended for use with an olympus ebus scope".There is evidence to suggest that the customer did not follow the instructions for use (ifu0109-5) in relation to the type of scope used.Engineering confirmed that this could be a potential root cause for the needle breakage root cause review: the failure of needle broken was observed in the laboratory.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 or scope used in a flexed position as indicated in the additional information.Another possible cause could be attributed to incompatible scope used.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.
Event or Problem Description
This follow up report is being submitted based on the receipt of additional information regarding the potential root cause of this complaint.Reference section h.10 for additional information.Initial report details: during procedure the tip broke off and could not be retrieved as of yet.As per complaint form: "during the procedure the needle tip broke off and could not be retrieved as of yet.".

• 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: 8173042
• Report Number: 3001845648-2018-00602
• Device Sequence Number: 1987092
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)210927(10)C1543956
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C1543956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention