MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The literature article is attached for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "endoscopic ultrasound-guided gastrojejunostomy for malignant afferent loop syndrome using a fully covered metal stent: a multicenter experience".Literature summary background: endoscopic-ultrasound-guided gastrojejunostomy (eus-gj) can be a new alternative for patients with malignant afferent loop syndrome (mals).However, a fully covered self-expandable metal stent (fcsems) has not been well investigated in this setting.Methods: this is a multicenter retrospective cohort study.Consecutive patients that underwent eus-gj using a fcsems for mals between (b)(6) 2017 and (b)(6) 2022 were enrolled.Primary outcomes were technical and clinical success rates.Secondary outcomes were adverse events, recurrent symptoms, and overall survival.Results: twelve patients (median age: 67.5 years (interquartile range: 58¿74.8); 50% male) were included.The most common primary disease and type of previous surgery were pancreatic cancer (67%) and pancreatoduodenectomy (75%), respectively.Technical success and clinical success were achieved in all patients.Procedure-related adverse events occurred in one patient (8%) with mild peritonitis.During a median follow-up of 96.5 days, one patient (8%) had recurrent symptoms due to the eus-gj stent dysfunction; including biliary events unrelated to the eus-gj stent, five patients (42%) had recurrent events.The median overall survival was 137 days.Nine patients (75%) died due to disease progression.Conclusions: eus-gj with a fcsems seems safe and effective for mals with high technical and clinical success rates and an acceptable recurrence rate.Type of adverse events/number of patients event 1: deaths- 9 patients event 2: mild peritonitis -1 patient this article requires 2 complaints: 1.(b)(6)/na-u200h-8019/deaths 2.(b)(6)/na-u200h-8019/ae (events other than death) this complaint is (b)(6).It was reported that procedure-related mild peritonitis occurred in one patient that resolved conservatively with antibiotics.Also noted were late onset adverse events of recurrent jaundice due to stent dysfunction in one patient, newly developed obstructive jaundice/cholangitis due to tumor progression in 3 patients and recurrent biliary obstruction due to existing biliary stents¿ dysfunction in 2 patients.These adverse events occurred after more than a month after the procedures.The late onset adverse events were unrelated and unassessable as the onsets were more than 1 month old.Mild peritonitis required intervention/treatment there is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or 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.Therefore, the root cause cannot be determined.This supplemental report includes information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following additional information was received: an olympus device did not cause or contribute to the adverse events described in the article.Also, no olympus device malfunction occurred during any of the events.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18345711
• Report Number: 9614641-2023-01934
• Device Sequence Number: 6202693
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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-8019
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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: SINGLE USE GUIDEWIRE G-260-2545A, SN-UNK
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown