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

Model Number	G52012
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510 (k) number: k092359.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
Upon advance the needle through the sheath, resistance was met, and the needle damaged the end of the sheath and damaged the scope.The scope now has a leak.The tech opened two more to test and both had difficulty advancing, so these two devices were not used and were discarded.These two devices did not make endoscope or patient contact.The tech mentioned that the elevator may have come down too hard on the device where the resistance was met; however, the other two devices which were tested had a similar issue, so this theory did fit for all devices.
Additional Manufacturer Narrative
510 (k) number: k092359.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to 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: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Upon advance the needle through the sheath, resistance was met, and the needle damaged the end of the sheath and damaged the scope.The scope now has a leak.The tech opened two more to test and both had difficulty advancing, so these two devices were not used and were discarded.These two devices did not make endoscope or patient contact.The tech mentioned that the elevator may have come down too hard on the device where the resistance was met; however, the other two devices which were tested had a similar issue, so this theory did fit for all devices.
Event or Problem Description
Upon advance the needle through the sheath, resistance was met, and the needle damaged the end of the sheath and damaged the scope.The scope now has a leak.The tech opened two more to test and both had difficulty advancing, so these two devices were not used and were discarded.These two devices did not make endoscope or patient contact.The tech mentioned that the elevator may have come down too hard on the device where the resistance was met; however, the other two devices which were tested had a similar issue, so this theory did fit for all devices.
Additional Manufacturer Narrative
510 (k) number: k092359.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.(b)(6) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Information pertaining to (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.
Additional Manufacturer Narrative
510 (k) number; k092359.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)(6).(b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the echo-hd-19-a device of lot number c1511249 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 03 october 2018.On laboratory evaluation of the returned device, it was noted that distal end of the sheath was defected.Syringe was missing.Able to advance and retract needle but with resistance.Able to advance and retract the stylet but with resistance.Following the laboratory evaluation additional information was requested to confirm if the sheath was visible exiting the scope and whether the elevator was in a neutral position when the sheath exited the scope.As per customer testimony "unfortunately, the individuals involved are not sure and cannot remember ¿ but they told me they think the sheath was not visible and that the elevator would be in neutral position.¿ 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, possible causes may have been when advancing the needle, it may have been advanced in a torturous position causing the needle to perforate the sheath, it also perforated the scope as there is a leak in the scope.Document review: components supplied by external suppliers are subject to incoming inspection as per iqc0499.Prior to distribution, all echo 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 instructed in d00055271(fqc0120) rev028 ¿check for visual defects, debris, loose or embedded foreign materials, rough or sharp edges, bends or kinks.¿ all products and packaging are 100% inspected for visual irregularities such as holes, dents, kinks or tears.There is a check on each device to measure the needle extension and inspect it to ensure it is free from any damage / kinks.A review of the manufacturing records for echo-hd-19-a devices of lot number c1511249 did not reveal any discrepancies which could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1511249; upon review of complaints this failure mode has not occurred previously with this lot # c1511249.Ifu review: the instructions for use, ifu0050-2, advises the user to ¿visually inspect with particular attention to kinks, bends or 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, ifu0050-2.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The customer complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Upon advance the needle through the sheath, resistance was met, and the needle damaged the end of the sheath and damaged the scope.The scope now has a leak.The tech opened two more to test and both had difficulty advancing, so these two devices were not used and were discarded.These two devices did not make endoscope or patient contact.The tech mentioned that the elevator may have come down too hard on the device where the resistance was met; however, the other two devices which were tested had a similar issue, so this theory did fit for all devices.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7910282
• Report Number: 3001845648-2018-00451
• Device Sequence Number: 1399849
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)210615(10)C1511249
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K092359
• 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
• Report Date (Section B): 11/21/2018

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: 06/15/2021
• Device Model Number: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: C1511249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018; 08/29/2018; 08/29/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/24/2018; 11/21/2018; 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1