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

Model Number	G31520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # k083330.1 x echo-19 of lot # c1580980 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 needle was found to be broken approximately 5.8 cm from tip of sheath.The needle was found to be kinked distally.The kink at distal end most likely a cascading effect of the needle break.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 c1580980 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.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.As per additional information received needle penetration of the targeted site was difficult.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
The needle broke during the procedure.
Additional Manufacturer Narrative
Pma/510(k) # k083330 1 x echo-19 of lot # c1580980 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 needle was found to be broken approximately 5.8 cm from tip of sheath.The needle was found to be kinked distally.The kink at distal end most likely a cascading effect of the needle break.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 c1580980 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.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.As per additional information received needle penetration of the targeted site was difficult.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
The needle broke during the procedure.A correction report is being submitted to classify this report under serious injury.Adopting a cautious approach, serious injury reporting required as the needle broke inside the patient's body and there is potentially a requirement for surgical intervention.The risk of this complaint was assessed based on a severity of +3 (harm requiring medical intervention).It should be noted that these details do not impact the evaluation conclusions previously submitted in relation to this event.

• 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: 8984217
• Report Number: 3001845648-2019-00462
• Device Sequence Number: 2664793
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)220130(10)C1580980
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 01/30/2022
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1580980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/01/2019
• 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
• Patient Age: 61 YR