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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire and three (3) fiducials that have not been deployed were included in the return.The stylet wire was returned extended 2.5 cm outside the proximal end of the handle.The stylet wire exhibited a bend near the area that was outside of the proximal end of the handle.The needle adjuster was placed on "8" and the needle advanced and retracted as expected when the handle was manipulated.The handle was manipulated forward in the advanced position and a visual inspection of the needle was performed.The needle exhibited a significant bend distal to the sheath.The needle was bent from the distal tip of the sheath to the distal tip of the bevel of the needle.A bend in the sheath was observed 3.2 cm from the base of the handle.The sheath being bent in this area can occur if the handle of the device is not attached to the biopsy port.In addition, a bend in the sheath and the needle in this area, can contribute to deployment difficulty.During a functional test the device was placed down an olympus gf-uc160p (3.2 mm channel endoscope) and the endoscope was placed in a curved position.The device advanced through the endoscope without resistance.The device was attached the biopsy port.The needle advanced and retracted when the handle was manipulated as intended.Once the needle was in the advanced position, pressure was applied to the thumb ring to deploy the fiducials.The fiducials did not deploy as the stylet wire began to bend significantly near the thumb ring.The device was taken out of the endoscope and the stylet wire was removed and replaced by a stylet wire from our lab stock.The device again advanced through the endoscope.Once the needle was in the advanced position, pressure was applied to the thumb ring to deploy the fiducials.Each fiducial deployed successfully.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use 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." 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, it could contribute to severe bending of the needle near the distal end.This contributes to advancement and/or retraction difficulties.The instruction for use states: "attach device to endoscope accessory channel port." the instructions for use cautions the user: "failure to attach device prior to needle adjustment or extension may result in damage to endoscope." 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) procedure with fiducial placement, the physician used a cook echotip ultra fiducial needle.Per the customer, the device came out of package with a bent tip [needle bent].They still tried to use it to see if it would still work.They did not have much success because it would not deploy but one time [one fiducial].

• 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: 7579261
• Report Number: 1037905-2018-00242
• Device Sequence Number: 16733024
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)190320(10)W4044759
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/07/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/07/2018
• Patient Sequence Number: 1