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

Model Number	G55736
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k142688 investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The needle kinked upon first puncture of the lesion.The needle was retracted back into the sheath, the doctor attempted a second puncture but failed because the needle was unable to come out from the sheath.Additional information confirmed that the needle was fully retracted with force prior to removal from patient.
Event or Problem Description
The needle kinked upon first puncture of the lesion.The needle was retracted back into the sheath, the doctor attempted a second puncture but failed because the needle was unable to come out from the sheath.Additional information confirmed that the needle was fully retracted with force prior to removal from patient.File is fda reportable based on reporting precedence for this device family for the issue of ¿non-retraction of needle".
Additional Manufacturer Narrative
Pma/510(k) #k142688, device evaluation: the echo-hd-22-c device of lot number c1542959 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 27nov2019.There was a kink at the distal end of needle (approximately 3cm from the tip of the needle) document review prior to distribution, all echo-hd-22-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 relevant manufacturing records (c1542959) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1542959.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4).Root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the flexed position of the endoscope.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.

• 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: 9456806
• Report Number: 3001845648-2019-00713
• Device Sequence Number: 11533260
• Product Code: FCG
• UDI-Device Identifier: 00827002557369
• UDI-Public: (01)00827002557369(17)210924(10)C1542959
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 12/12/2019

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: 09/24/2021
• Device Model Number: G55736
• Device Catalogue Number: ECHO-HD-22-C
• Device Lot Number: C1542959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1