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

Catalog Number ECHO-22-F

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.A review of the device history record could not be conducted because the lot number was not provided.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 states under system preparation: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker.Note: excessive pressure on stylet may result in premature deployment." 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." the user stated that needle penetration of the targeted site was difficult.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.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.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 cookechotip ultra fiducial needle.The doctor stuck the needle in the lesion.He said he felt something weird, so he drew the needle back and all the fiducials were deployed without touching the stylet.The information provided on 01/12/18 indicated that the needle was bent.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The four (4) fiducials were not included in the returned device.The stylet wire exhibited a slight bend in the wire approximately 4 cm from the base of the thumb ring handle.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.A bend in the sheath was observed at 4.2 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.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.Attempts were made to measure the needle along with the slot the fiducials are placed in, however due to the condition of the needle, dimensional verification was not successful.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: a definitive cause for this observation 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.The instructions for use states under system preparation: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker.Note: excessive pressure on stylet may result in premature deployment." 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." the user stated that needle penetration of the targeted site was difficult.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.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.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.H3 other text : investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The four (4) fiducials were not included in the returned device.The stylet wire exhibited a slight bend in the wire approximately 4 cm from the base of the thumb ring handle.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.A bend in the sheath was observed at 4.2 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.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.Attempts were made to measure the needle along with the slot the fiducials are placed in, however due to the condition of the needle, dimensional verification was not successful.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: a definitive cause for this observation 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.The instructions for use states under system preparation: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker.Note: excessive pressure on stylet may result in premature deployment." 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." the user stated that needle penetration of the targeted site was difficult.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.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.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.

• 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
• MDR Report Key: 7244828
• MDR Text Key: 99790912
• Report Number: 1037905-2018-00043
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GF-UCT180 ENDOSCOPE