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	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1-facility name: (b)(6).The reports of the following patient identifiers are linked: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled "emergent treatment using balloon-assisted ercp versus eus-guided drainage for acute cholangitis in patients with surgically altered anatomy.¿ background: no studies have compared balloon-assisted endoscope-guided endoscopic retrograde cholangiopancreatography (bae-ercp) and endoscopic ultrasonography-guided biliary drainage (eus-bd) for emergent treatment of acute cholangitis (ac) in patients with upper gastrointestinal surgically altered anatomy (saa).Methods: this study retrospectively evaluated consecutive patients who underwent emergent bae-ercp or eus-bd for ac with saa between january 2020 and march 2024.Technical success, clinical success, procedure time, and adverse events (aes) were compared between the two groups.Results: this study included 23 patients in the bae-ercp group and 14 patients in the eus-bd group.Technical success and clinical success rates did not significantly differ between the two groups (88% vs.100%, p = 0.51 and 95% vs.93%, p = 0.66).Similarly, the rate of aes was comparable between the two groups (4% vs.14%, p = 0.54).The median procedure time was significantly shorter in the eus-bd group than in the bae-ercp group (32.5 [interquartile range; iqr, 28.8¿52.5] minutes vs.70.0 [iqr, 60.0¿90.0] minutes, p < 0.01).In cases with grade 2 or 3 cholangitis, the rates of technical success, clinical success, and aes did not significantly differ between the two groups.However, the median procedure time was significantly shorter in the eus-bd group than in the bae-ercp group (32.5 [iqr, 28.8¿52.5] minutes vs.70 [iqr, 56.3¿90.0] minutes, p < 0.01).Conclusion: while both bae-ercp and eus-bd can be performed safely and effectively in patients with ac and saa, the procedure time is significantly shorter with eus-bd than with bae-ercp.Type of adverse events/number of patients peritonitis (2 patients).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: b5, h6.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information received from the author that confirmed no device malfunctioned, and no device caused or contributed to the adverse 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21576718
• Report Number: 9614641-2025-00295
• Device Sequence Number: 15521774
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: GF-UCT260 GASTROVIDEOSCOPE
• Patient Sex: Unknown