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)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved determined the needle had a significant bend.During the return of the device, the handle of the device was manipulated.When the handle of the device was manipulated the needle would advance and retract.The handle of the device felt rough when advancing the needle outside the distal end of the sheath.When the needle was advanced outside the distal end of the sheath, a visual inspection of the needle was performed and we determined that the needle of the device was significantly bent.The bend in the needle occurred at 5 cm from the distal end of the sheath.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".The needle would advance and retract.When manipulating the handle during advancement, the handle of the device felt rough.The device was disassembled to verify the needle was not broken and we confirmed that the needle was fully intact.When visually inspecting the needle, the needle exhibited additional bends from 19 cm to 42 cm from the proximal end.The area of the needle that was kinked would have most likely been inside of the handle when the device was assembled.The kinking in this area of the needle could have contributed to the grinding feeling when the handle was manipulated.When disassembling the device, the metal luer lock at the proximal end of the handle broke off of the needle.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: "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." "introduce ultrasound needle into accessory channel and advance device in small increments until luer lock fitting at base of sliding sheath adjuster meets fitting on accessory channel." "attach device to accessory channel port by rotating device handle until fittings are connected." "with ultrasound endoscope and device straight, adjust needle to desired length by loosening thumbscrew on safety ring, and advancing it until desired reference mark for needle advancement appears in window of safety ring.Tighten thumbscrew to lock safety ring in place.Caution: during needle adjustment or extension, ensure device has been attached to accessory channel.Failure to attach device prior to needle adjustment or extension may result in damage to endoscope." if excessive pressure is applied to the device, bends or kinks can occur.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.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 operator adjusted the sheath to a suitable length and was ready to advance, but it failed after several tries ((b)(4)).The device was evaluated on 04/13/2018 and it was observed that there was a significant bend at the patient end of the needle.

• 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: 7494480
• Report Number: 1037905-2018-00194
• Device Sequence Number: 239141
• Product Code: FCG
• UDI-Device Identifier: 00827002315211
• UDI-Public: (01)00827002315211(17)200912(10)W3917224
• 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,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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 Catalogue Number: ECHO-3-22
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1