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 Codes	Pulmonary Embolism (1498); Abdominal Pain (1685); Bradycardia (1751); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Perforation (2001); Peritonitis (2252); Respiratory Failure (2484); Aspiration Pneumonitis (4455); Pancreatitis (4481); Cholangitis (4821)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the article, "ercp using balloon-assisted endoscopes versus eus-guided treatment for common bile duct stones in roux-en-y gastrectomy." consecutive patients who had previous roux-en-y (r-y) gastrectomy undergoing balloon-assisted endoscope (be-ercp) or eus-guided antegrade treatment (eus-ag) for common bile duct (cbd) stones in 16 centers were retrospectively analyzed.Patients who underwent endoscopic interventions between january 2009 and march 2020 were enrolled.Balloon-assisted endoscopic retrograde cholangiopancreatography (ercp): type of adverse events/number of patients pancreatitis (23) cholangitis (7) cholecystitis (1) major or minor perforation (15) laceration (3) bleeding (3) aspiration pneumoniae (4) respiratory failure (2) pulmonary embolism (1) bradycardia (1) endoscopic ultrasound (eus)-guided antegrade treatment: type of adverse events/number of patients cholangitis (3) cholecystitis (1) bile peritonitis (2) abdominal pain with fever (5) the selection of the intervention was at the discretion of endo- scopists.When the initial procedure failed, an alternative treatment was chosen from another endoscopic intervention, percutaneous transhepatic biliary drainage, surgical care, and conservative management.
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The device was not returned.Attempts were performed to obtain additional information, but no response was received.Should additional relevant information become available, a supplemental report will be submitted.
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, a 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.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): 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: 19640041
• Report Number: 9614641-2024-01357
• Device Sequence Number: 7093203
• 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): 08/02/2024

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: 06/03/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/02/2024
• 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: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE (GIF-N260); EVIS LUCERA INTESTINAL VIDEOSCOPE (SIF-H290S); EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE (SIF-Q260); EVIS LUCERA US GASTROVIDEOSCOPE (GF-UCT260); ULTRASONIC GASTROVIDEOSCOPE (GF-UCT240)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown