MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number	HX-201UR-135
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2023
Type of Reportable Event	Death
Event or Problem Description
Olympus reviewed the following literature "outcomes of endoscopic papillectomy of ampullary carcinoma and factors affecting additional surgery." this retrospective study aimed to clarify the outcomes of patients with ampullary carcinoma (ac) treated with endoscopic papillectomy (ep) and identify factors that can predict successful control of ac by endoscopic treatment.A total of 75 patients were included.The 3-year endoscopic tumor control (condition not requiring additional surgery) rates in the m and od groups were 90.8% and 84.6% (p=.033), respectively.The 3-year endoscopic tumor control rate was 100% in patients with negative or uncertain resection margins and 76.6% in those with positive margins (p=.009).Type of adverse events/number of patients treatment-related death (1).An 82 year old male with an 11mm tumor underwent surgery for a positive margin with carcinoma and died of a treatment-related death.
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, 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 additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
Event or Problem Description
An olympus device did not cause or contribute to the adverse events described in the article.Also, it was confirmed that there was no malfunction of an olympus device.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Common Device Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• 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: 19053566
• Report Number: 9614641-2024-00858
• Device Sequence Number: 18184644
• Product Code: PKL
• UDI-Device Identifier: 04953170353123
• UDI-Public: 04953170353123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• 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): 04/15/2024

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: HX-201UR-135
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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: DISPOSABLE ELECTROSURGICAL SNARE (SD-230U-20).; EVIS LUCERA DUODENOVIDEOSCOPE (TJF-260V).; EVIS LUCERA ELITE DUODENOVIDEOSCOPE (TJF-Q290V).
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male