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

Catalog Number	ECHO-3-22
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.A visual inspection of the returned device found that the needle had a bend at the distal end when the needle was outside the sheath.The stylet wire or the locking syringe was not returned for evaluation.Two bends were in the sheath near the handle at 2.8 cm from the handle and 12.5 cm from the handle.The user stated that the device was "prior to use", however these bends could have occurred if the device was placed down the scope and the handle was not properly seated on the biopsy channel port.The length of the sheath is 142.5 cm which is within specification (142.7 cm +/- 2 mm).With the needle adjuster set on "8" and the sheath adjuster set on "5", the needle is bent at 146.2 cm from the base of the handle.The bevel of the needle is uniform and intact.A functional test was performed by placing the device down an olympus gf-uc160p endoscope.Once the device was placed down the endoscope, the scope was placed in a curved position to simulate a worst-case scenario.The needle adjuster was on "8" and the handle was manipulated.The needle of the device advanced and retracted as intended.With the needle advanced outside the distal end of the sheath, the bend in the needle was observed.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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.If excessive pressure is applied to the device, bends or kinks can occur.The instructions for use under precautions states: "needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold needle in place prior to introduction, advancement or withdrawal of device.Failure to retract needle may result in damage to 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
In preparation for a procedure, the user selected a cook echotip ultra endoscopic ultrasound needle.When the user opened the packaging, the catheter was noted to be bent.

• 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: 6760385
• Report Number: 1037905-2017-00515
• Device Sequence Number: 2064796
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)200321(10)W3843033
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K934356
• 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): 08/02/2017

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 Catalogue Number: ECHO-3-22
• 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: 07/12/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1