MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 2-LUMEN SPHINCTEROTOME V

Model Number	KD-V211M-0725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481); Cholangitis (4821)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
Olympus reviewed the following literature titled "long-term results of endoscopic metal stenting for biliary anastomotic stricture after liver transplantation." anastomotic biliary stricture (abs) is a well-known complication of liver transplantation which can lead to secondary biliary cirrhosis and graft dysfunction.The goal of this study was to evaluate the long-term outcomes of endoscopic metal stenting of abs in the setting of deceased donor liver transplantation (ddlt).Consecutive ddlt patients with endoscopic metal stenting for abs between 2010 and 2015 were screened.Data on diagnosis, treatment and follow-up (until june 2022) were collected.The primary outcome was endoscopic treatment failure defined as the need for surgical refection.Results: among the 465 patients who underwent lt, 41 developed abs.It was diagnosed after a mean period of 7.4 months (+/- 10.6) following lt.Endoscopic treatment was technically successful in 95.1% of cases.The mean duration of endoscopic treatment was 12.8 months (+/- 9.1) and 53.7% of patients completed a 1-year treatment.After a mean follow-up of 6.9 years (+/- 2.3), endoscopic treatment failed in nine patients (22%) who required surgical refection.Conclusions: endoscopic management with metal stenting of abs after ddlt was technically successful in most cases, and half of the patients had at least one year of indwelling stent.Endoscopic treatment long-term failure rate occurred in one fifth of the patients.Type of adverse events/number of patients: post-sphincterotomy bleeding - four patients; post-ercp pancreatitis - six patients; cholangitis - two patients.There was no report of any olympus device malfunction in any procedure described in this study.
Event or Problem Description
Additional information reported by the author indicated that no olympus device malfunctioned, nor did it cause or contribute to any adverse event described in the literature.It was confirmed that serial/lot number information was not available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional data to b5.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.
Event or Problem Description
This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for patient identifier (b)(6).

• Brand Name: SINGLE USE 2-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• 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: 16569796
• Report Number: 9614641-2023-00394
• Device Sequence Number: 20368124
• Product Code: KNS
• UDI-Device Identifier: 04953170382734
• UDI-Public: 04953170382734
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950166
• 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,Followup
• Report Date (Section B): 05/05/2023

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: KD-V211M-0725
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/19/2023; 04/18/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 03/20/2023; 05/05/2023
• 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: NON OLYMPUS BILIARY STENT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown