MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8022S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature "case report transjejunal endoscopic ultrasound-guided pancreatic drainage for pancreatic jejunostomy stricture using a forward-viewing echoendoscope in a patient with altered anatomy."     literature summary: pancreatic jejunostomy stricture (pjs) is one of the major late complications after pancreaticoduodenectomy.Endoscopic ultrasound-guided pancreatic drainage (eus-pd) is considered a salvage treatment for symptomatic pjs after endoscopic retrograde pancreatography failure; however, the technical success rate of the endoscopic treatment of pjs remains unsatisfactory, mainly due to surgically altered anatomy.Herein, we describe a case of pjs successfully treated with transjejunal eus-pd using a forward-viewing echoendoscope.A (b)(6) man who suffered from repetitive severe back pain due to pjs was referred to our hospital.Since transgastric eus-pd was difficult, we attempted transjejunal eus-pd using a forward-viewing echoendoscope.To facilitate scope insertion, we first straightened the afferent jejuna! loop and placed a stiff guidewire.With this scheme, we successfully performed transjejunal eus-pd and placed a 5-fr plastic stent.In conclusion, this technique is useful for treating patients with pjs when transgastric euspd is difficult.    type of adverse events/number of patients: acute pancreatitis n=1.  this article includes 3 reports: patient identifier (b)(6): na-u200h-8019, the literature described "19g ez shot 3plus", we selected "na-u200h-8019" as a representative product.Patient identifier (b)(6): (b)(4).Patient identifier (b)(6): (b)(4).This report is 1 of 3 for patient identifier (b)(6): na-u200h-8019, the literature described "19g ez shot 3plus", we selected "na-u200h-8019" as a representative product.
Event or Problem Description
Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.The author stated: it is possible that the slight shift in the puncture position contributed to pancreatic leakage from the side hole of the puncture needle, but there is no product problem.The author provided the model number as na-u200h-8022s (lot unknown).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and a correction.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14548280
• Report Number: 8010047-2022-09111
• Device Sequence Number: 17395229
• Product Code: FCG
• UDI-Device Identifier: 04953170380525
• UDI-Public: 04953170380525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8022S
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SERIAL: (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male