MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BENDING CANNULA; DISPOSABLE CANNULA

Model Number	PR-233Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pancreatitis (4481); Cholangitis (4821)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "swingtip", olympus selected "pr-233q" as a representative product.This report is related to the following 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.
Event or Problem Description
Olympus reviewed the following literature titled "a multicenter study of short sbe-assisted biliary cannulation using texture and color enhancement imaging (txi) in patients with roux-en-y after gastrectomy" literature summary deep intubation of the bile duct under balloon endoscopy is not easy for patients with roux-en-y after gastrectomy.Texture and color enhancement imaging (txi), which is incorporated in the recently introduced endoscopic system evis x1 (olympus), optimizes the structure, color tone, and brightness of the mucosa, enhances slight changes in color tone and structure, improves the identification of the papillary region, and may be useful for deep bile duct it has been reported that this technique may be useful for deep intubation of the bile duct.We investigated the usefulness of deep bile duct intubation using txi in patients with roux-en-y after gastrectomy.The following events have been reported in the literature: pancreatitis -7.Cholangitis-2.Intestinal perforation (moderate)-3.
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: DISPOSABLE BENDING CANNULA
• Common Device Name: DISPOSABLE CANNULA
• 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: 19563638
• Report Number: 9614641-2024-01275
• Device Sequence Number: 15340868
• Product Code: ODD
• UDI-Device Identifier: 04953170044243
• UDI-Public: 04953170044243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011149
• 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): 06/27/2024

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: PR-233Q
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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: SIF-H290S
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown