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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k083330.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Device was advanced to target area and 3 attempts were completed.User cannot advance the needle after third attempt, and found out the needle broken under endoscopy view.User changed another same device to complete the procedure.
Event or Problem Description
Device was advanced to target area and 3 attempts were completed.User cannot advance the needle after third attempt, and found out the needle broken under endoscopy view.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
Pma/510(k) # k083330.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Device was advanced to target area and 3 attempts were completed.User cannot advance the needle after third attempt, and found out the needle broken under endoscopy view.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
Complaint device was not returned therefore a document based review will be performed.It was indicated that complaint device was to be returned but has not been returned to date.If it is returned in the future then the file will be updated accordingly.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 c1563789 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 could not be determined from the available information.From the information provided the failure of needle broken was concluded.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to advancement into a hard lesion.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Complaint is confirmed based on the customer's testimony.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.
Additional Manufacturer Narrative
Pma/510(k)#: k083330.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Device was advanced to target area and 3 attempts were completed.User cannot advance the needle after third attempt, and found out the needle broken under endoscopy view.User changed another same device to complete the procedure.

• 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: 8915547
• Report Number: 3001845648-2019-00426
• Device Sequence Number: 19285701
• Product Code: FCG
• UDI-Device Identifier: 00827002315204
• UDI-Public: (01)00827002315204(17)211129(10)C1563789
• 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,Followup,Followup
• Report Date (Section B): 10/16/2019

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: 11/29/2021
• Device Model Number: G31520
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1563789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019; 07/25/2019; 07/25/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/18/2019; 10/16/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 79