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

Model Number	G31520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #k083330.(b)(4).Exemption number: e2016031.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
They checked that mass location was body of pancreas before the procedure in eus.They advanced echo-19 to mass in through the scope.However, the needle didn't puncture to mass in eus.Consequently, the needle was removed out of the scope.So they used another echo-19 device.
Event or Problem Description
They checked that mass location was body of pancreas before the procedure in eus.They advanced echo-19 to mass in through the scope.However, the needle didn't puncture to mass in eus.Consequently, the needle was removed out of the scope.So they used another echo-19 device.
Additional Manufacturer Narrative
Pma/510(k) #k083330.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(6) (importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).1 x echo-19 of lot # c1551829 was returned to cirl for evaluation open in its 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.The tip of the needle was found to be deformed/bent.Prior to distribution, all echo-19 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-19 of lot number c1551829 did not reveal any discrepancies that could have contributed to this complaint issue.The notes section of the instructions for use, 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 no evidence to suggest that the customer did not follow the instructions for use.The failure of needle tip bent 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 advancement into a hard lesion.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.

• 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: 8826586
• Report Number: 3001845648-2019-00368
• Device Sequence Number: 2654388
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)211022(10)C1551829
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 10/22/2021
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1551829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 63