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

Model Number G03793

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined the needle had a significant bend at the patient end.The stylet wire and four (4) fiducials that have not been deployed were included in the return.The stylet did exhibit a slight bend near the proximal thumb ring handle.The stylet wire was sticking out 1.9 cm from the proximal end of the handle.The user stated that the stylet wire was found to be kinked prior to the procedure.This could have contributed to user not being able to advance the fiducial markers.The needle adjuster was placed on "8" and the needle would advance and retract 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 needle.It is difficult to determine when the bend in the needle occurred.A bend in the sheath was observed at 3.1 cm from the base of the handle.The bend in the sheath was almost at a 90 degree angle.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 scope) and the endoscope was placed in a curved position.The needle would advance and retract when the handle was manipulated as intended.An attempt was made to deploy the fiducials using the stylet wire provided in the return.After several attempts, the fiducials would not deploy.The stylet wire continued to bend even more when pressure was applied to the thumb ring.The device was removed from the endoscope to remove the stylet wire.The returned stylet wire was removed and a stylet wire from our lab stock was used.When advancing the stylet wire through the device, the stylet wire would not advance.The stylet wire would not advance due to the severe bend to the sheath near the base of the handle.The bend in this area could have contributed to the user's deployment difficulty.The fiducials were manually removed from the device.A dimensional verification under magnification was performed on the needle and the slot the fiducials are placed in and the fiducials.The width of small slot that opens up when the fiducials being deployed met the specification.The large slot which the fiducials rest in prior to deployment met the specification.The length of the fiducial slot was not measured due to the bend in the needle.The needle was bent in a way that prevented an accurate measurement.Further, all four (4) fiducials were returned and measured.The length of the four (4) fiducials measured to be in tolerance.All tab lengths of the fiducials were in tolerance, and all four (4) fiducials met the required height specifications.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 user reported the stylet wire was bent when the device was removed from the package and they continued to use the device but were unable to advance fiducial markers due to the bent stylet.A definitive cause for the report of a bent stylet could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.Use of a device with a bent stylet would result in difficulty deploying the fiducials.The instructions for use state: ¿visually inspect with particular attention to kinks, bends, and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Please notify cook for return authorization.¿ the instructions for use states under system preparation: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker." bends kinks in the styler wire can contribute to not being able to deploy the fiducial markers.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." 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.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 Description

During an endoscopic ultrasonography (eus), the physician used a cook echotip ulta fiducial needle.The stylet was bent when the needle was in the [package].The user went ahead [and used the device, and was] unable to advance fiducial markers due to the bent stylet.The procedure was completed with another device.There was no reportable information at this time.The device was evaluated on 02/26/2018 and it was observed the needle had a significant kink in the patient end of the needle.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7366902
• MDR Text Key: 103435232
• Report Number: 1037905-2018-00111
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)190103(10)W4013181
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1