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COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
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| Model Number G03793 |
| Device Problem
Material Twisted/Bent (2981)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 07/26/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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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) includes the following to ensure proper use of the device: ¿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.¿ ¿attach device to endoscope accessory channel port.¿ 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.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.
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Event Description
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During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra fiducial needle.Once introduced into the instrument [endoscope] when the needle was ejected from its shirt [sheath], it came out folded [bent].So, they used another fiducial needle.Always in account / vision, which worked perfectly [sic].The following additional information was received on 08-aug-2018: the needle exited from the sheath bent at 90 degrees.The user used another device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Event Description
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During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra fiducial needle.Once introduced into the instrument [endoscope] when the needle was ejected from its shirt [sheath], it came out folded [bent].So, they used another fiducial needle.Always in account / vision, which worked perfectly [sic].The following additional information was received on 08-aug-2018: the needle exited from the sheath bent at 90 degrees.The user used another device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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This report is being sent to correct the investigation conclusion in additional manufacture narrative.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire and all four (4) fiducials were included in the return of the device.All four (4) fiducials were returned not deployed and still in the needle during the return.The stylet wire was returned with a slight bend in the proximal end.The bend was not a sharp bend, but more of a slight curve.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 sharp bend distal to the sheath.The sharp bend in the needle was 5.5 cm from the distal tip of the sheath.During a functional test the stylet wire of the device was removed and replaced with a stylet wire from our lab stock that did not exhibit any kinks.The device was placed down an olympus gf-uc160p (3.2 mm channel scope) and the endoscope was placed in a curved position.When pressure was applied to the thumb ring, the thumb ring bent, and deployment of the fiducials was unsuccessful.After multiple attempts, the endoscope was placed in a straight position, however deployment of the fiducials was still unsuccessful.The sharp bend in the needle is the most likely cause of why the fiducials will not deploy.The fiducial markers were manually removed from the device so that dimensional verification could be performed on the needle, the slot the fiducial markers are placed in, and the individual fiducial markers.The length of the fiducial slot was unable to be measured accurately due to the sharp bend in the needle.The width of the small slot that opens up when the fiducials are being deployed met the specified tolerance.The large slot which the fiducials rest in prior to deployment met the specification.The length from the first dimple to the distal tip of the bevel met the specification.The four (4) fiducials were measured.All four (4) fiducials met the specified criteria.The tab length was measured and all four (4) fiducials meet the specified criteria for the tab length.The overall height of the fiducials met the specified height requirement.The last measurement taken on the fiducial was the tab width.The tab width on all four fiducials met the specified criteria.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 (ifu) includes the following to ensure proper use of the device: ¿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.¿ ¿attach device to endoscope accessory channel port.¿ 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.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.
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Event Description
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During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra fiducial needle.Once introduced into the instrument [endoscope] when the needle was ejected from its shirt [sheath], it came out folded [bent].So, they used another fiducial needle.Always in account / vision, which worked perfectly [sic].The following additional information was received on 08-aug-2018: the needle exited from the sheath bent at 90 degrees.The user used another device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Continued from section h6 event and problem and evaluation codes: conclusion code- 4315 cause not established investigation evaluation.Our laboratory evaluation of the product said to be involved confirmed the report.The stylet wire and all four (4) fiducials were included in the return of the device.All four (4) fiducials were returned not deployed and still in the needle during the return.The stylet wire was returned with a slight bend in the proximal end.The bend was not a sharp bend, but more of a slight curve.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 sharp bend distal to the sheath.The sharp bend in the needle was 5.5 cm from the distal tip of the sheath.During a functional test the stylet wire of the device was removed and replaced with a stylet wire from our lab stock that did not exhibit any kinks.The device was placed down an olympus gf-uc160p (3.2 mm channel scope) and the endoscope was placed in a curved position.When pressure was applied to the thumb ring, the thumb ring bent, and deployment of the fiducials was unsuccessful.After multiple attempts, the endoscope was placed in a straight position, however deployment of the fiducials was still unsuccessful.The sharp bend in the needle is the most likely cause of why the fiducials will not deploy.The fiducial markers were manually removed from the device so that dimensional verification could be performed on the needle, the slot the fiducial markers are placed in, and the individual fiducial markers.The length of the fiducial slot was unable to be measured accurately due to the sharp bend in the needle.The width of the small slot that opens up when the fiducials are being deployed met the specified tolerance.The large slot which the fiducials rest in prior to deployment met the specification.The length from the first dimple to the distal tip of the bevel met the specification.The four (4) fiducials were measured.All four (4) fiducials met the specified criteria.The tab length was measured and all four (4) fiducials meet the specified criteria for the tab length.The overall height of the fiducials met the specified height requirement.The last measurement taken on the fiducial was the tab width.The tab width on all four fiducials met the specified criteria.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) includs the following to ensure proper use of the device: ¿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.¿ ¿attach device to endoscope accessory channel port.¿ 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.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.
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