MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

Model Number	G03793
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use (ifu) state, "if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the ifu states: "identify desired site based on previous findings from endoscopy, radiography and/or ct scans.Slowly introduce needle into accessory channel of endoscope and advance in short increments.Ensure needle is completely retracted and locked in place.Note: bends or kinks in needle caused by improper introduction may result in the inability to deploy fiducials." the user stated that the device was in an acute position and that the needle was bent at the distal end of the device as a result of the endoscope position.It is possible that if the needle is bent during introduction, becomes bent prior to reaching the identified site, or bends as a result of a hard mass, this could contribute to user's inability to deploy the fiducial markers.It is possible that if the needle is against or inside a hard mass while the user applies force and manipulates the directional controls of the endoscope, this could contribute to severe bending of the needle near the distal end.This contributes to advancement and/or retraction difficulties.Kinks in the needle can occur if the device experiences excessive pressure during product handling/preparation.Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection 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: 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 ultrasonography (eus), the physician used a cook echotip ultra fiducial needle.The scope was bent in an acute position.[the user was] unable to deploy the fiducials.Two (2) devices were used during this procedure [see related mdr 1037905-2018-00131].A third device was used to complete the procedure.The additional information received with the complaint information indicates that the needle was bent at an unknown location [subject of this report].Clarification was received on 03/21/18 indicating the bend was at the patient end of the device.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Common Device Name: NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7397116
• Report Number: 1037905-2018-00132
• Device Sequence Number: 11071076
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)190109(10)W4016712
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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 Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2018
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1