MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE; FCG, BIOPSY NEEDLE KIT

Model Number	G03793
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was visually evaluated.The device was returned with the needle fully extended, while the handle was in a retracted position.The stylet wire was sticking out on the proximal end.During a functional test, the handle of the device was manipulated several times and the needle did not retract.The handle provided no resistance and the needle did not seem to be moving inside the sheath or the handle.The handle was disassembled for further evaluation, and it was confirmed that the needle had separated from the inner cannula.The needle was removed from the device and examined at the attachment point with the inner cannula.There is evidence of glue on the proximal end of the needle, in-between the marked areas.During a visual examination there were a few bends noted throughout the length of the device, which were not visible while the needle was inside the sheath.All four fiducial markers were present and none of them were deployed.The bevel of the needle was still intact.A meeting was held with production on 04-mar-2020, and it was confirmed that the device was assembled properly.Production also confirmed there was sufficient glue visible to attach the needle to the inner cannula.Production noted that if the needle had experienced those bends during assembly, that it would have not been possible to assemble the needle into the handle.The device more than likely experienced an excessive force during product handling or shipping.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the root cause of being able to advance or retract the needle was a failure of the glued connection between the inner cannula and the needle on the proximal end.The detachment occurred inside the handle and this led to the report of unable to advance the needle.The cause of the joint failure is unknown.Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic procedure, the physician used a cook echotip ultra fiducial needle.The device completely did not work and the needle did not even come out of the sheath.It is unknown how the procedure was completed.This event was not reportable at the time.On (b)(6) 2020 the device was evaluated and it was determined the needle had separated from the inner catheter.This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Common Device Name: FCG, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9832447
• Report Number: 1037905-2020-00135
• Device Sequence Number: 10953759
• Product Code: FCG
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)200816(10)W4250814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 08/16/2020
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W4250814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial 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