MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-10704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bowel Perforation (2668); Pancreatitis (4481); Cholangitis (4821)
Date of Event	03/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the article "efficacy of texture and color enhancement imaging for short-type single-balloon enteroscopy-assisted biliary cannulation in patients with roux-en-y gastrectomy: multicenter study (with video)".This multicenter study evaluated the efficacy of short-type single-balloon enteroscopy (sbe)-assisted biliary cannulation using a new-generation image-enhanced endoscopy processing system equipped with txi in patients who underwent roux-en-y gastrectomy.Patients with roux-en-y gastrectomy with a native papilla, and underwent short sbe-assisted biliary cannulation during endoscopic retrograde cholangiopancreatography related procedures between january 2019 and april 2023 were retrospectively reviewed.Adverse events were defined and graded according to the american society for gastrointestinal endoscopy severity grading system.Type of adverse events/number of patients pancreatitis: mild (6).Cholangitis: mild (2).Intestinal perforation: moderate (3).All patients who experienced adverse events recovered after conservative therapy.
Additional Manufacturer Narrative
This report is related to patient identifier (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, the relationship between the device and the adverse events 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: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• 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: 19652690
• Report Number: 9614641-2024-01366
• Device Sequence Number: 20559047
• Product Code: FDS
• UDI-Device Identifier: 04953170278266
• UDI-Public: 04953170278266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• 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): 07/31/2024

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: D-201-10704
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/31/2024
• 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 ELITE INTESTINAL VIDEOSCOPE SIF-H290S.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown