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

Model Number	G31519
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When package was open, stylet was already out of place.Went ahead to check, the fna shift was bent (the point connecting fna shift and handle).Unable to push stylet in as well.Stylet kinked when it was re-inserted after pulling out.Device was returned and evaluated on 16-jan-2020 and a kink was noted below the sheath extender.
Additional Manufacturer Narrative
1 unit of lot number c1618338 of echo-25 was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation.A proximal kink was observed below the sheath extender.There was a second proximal kink also noted.The stylet was unable to be inserted into the device.Stylet removed and no kink observed.Prior to distribution, all echo-25 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-25 of lot number c1618338 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1618338.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 transportation, storage facilities or handling of the packaging after the device left the manufacturing facility or potentially on removal of the device from the packaging which may have caused the kinks and in turn would have led to the stylet advancement issue.A capa has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, this observation was made prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
When package was open, stylet was already out of place.Went ahead to check, the fna shift was bent (the point connecting fna shift and handle).Unable to push stylet in as well.Stylet kinked when it was re-inserted after pulling out.Device was returned and evaluated on 16-jan-2020 and a kink was noted below the sheath extender.

• 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: 9710579
• Report Number: 3001845648-2020-00088
• Device Sequence Number: 3128850
• Product Code: FCG
• UDI-Device Identifier: 00827002315198
• UDI-Public: (01)00827002315198(17)220529(10)C1618338
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 05/29/2022
• Device Model Number: G31519
• Device Catalogue Number: ECHO-25
• Device Lot Number: C1618338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1