MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG, BIOPSY NEEDLE KIT

Catalog Number	ECHO-3-22
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from section occupation: non-healthcare professional.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.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 could contribute to advancement and/or retraction difficulties.A kink in the needle and outer sheath can prevent movement of the needle and/or stylet.The stylet provides additional stiffness during advancement of the needle into the lesion.If the needle is removed from the endoscope to collect a sample the stylet must be reinserted prior to advancing the needle through the endoscope.Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 endoscopic ultrasound needle.The needle cannot be retracted into the sheath during the procedure (puncture).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.
Event or Problem Description
During an endoscopic ultrasonography (eus), the physician used a cook echotip ultra endoscopic ultrasound needle.The needle cannot be retracted into the sheath during the procedure (puncture).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.
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.A visual inspection was performed while removing the device from the open tray.During the visual inspection, the distal end of the sheath was observed and the needle was returned fully retracted inside the sheath.The handle of the device corresponded with the needle of the device.The needle adjuster was adjusted to position "8" and the sheath adjuster was adjusted to "5".When the handle of the device was manipulated, the needle of the device advanced and retracted as intended.During the visual inspection of the device, no bends or kinks in the device was noted.During a functional test, the device was advanced down an olympus gf-uct160p ultrasonic endoscope.Once the device was advanced outside the distal end of the endoscope, the endoscope was placed in a curved position.The luer lock at the distal end of the handle was attached to the biopsy port and the needle adjuster was placed on "8 and the sheath adjuster was adjusted to "5".When the handle was manipulated the needle would advance and retract.During a visual inspection there was no observation of needle exposure when the handle of the device is in the retracted position.The device was then tested by adjusting the sheath adjuster to "2".Again, when the handle was manipulate the needle would advance and retract smoothly.There was not any needle exposure when the handle of the device was in the retracted position.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 the reported observation could not be determined because the product said to be involved functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all echotip ultra endoscopic ultrasound needles are subjected to a visual inspection and functional testing 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 ENDOSCOPIC ULTRASOUND NEEDLE
• Common Device Name: FCG, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7781250
• Report Number: 1037905-2018-00353
• Device Sequence Number: 1399668
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)210125(10)W4021622
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K171596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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 Expiration Date: 01/25/2021
• Device Catalogue Number: ECHO-3-22
• Device Lot Number: W4021622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FUJINON 8000 ENDOSCOPE
• Patient Age: 67 YR
• Patient Weight: 65