MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	01/05/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that there was a fatal incident/death occurred due to a major bleeding after an ¿est¿ case (papillotomy of the duodenum) due to wrong direction of the single use 3-lumen sphincterotome used during the procedure.Reportedly, there was no fault with the device.Follow-up update stated that "est" procedure was completed end of last year and at the beginning of the year, bleeding occurred when the eplbd was performed with a balloon (endoscopic papillary large balloon dilation) and the stone was removed and sems ((self expandible metallic stent) was placed.That night the patient vomited blood and the sems deviated to the nipple side, perforation occurred, and patient suffered major bleeding leading to death.Follow-up with the customer was conducted for patient/ procedural details, medical/surgical intervention/treatment given and event details; however, no further update has been received at the time of the report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was determined that the patient death was not caused by the subject device.However, the root cause could not be determined.This supplemental report includes a correction to d4 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the patient underwent an endoscopic sphincterotomy (est) procedure on (b)(6) 2023.The endoscopic papillary large balloon dilatation (eplbd) was performed over a week later ((b)(6) 2024).Although the estimated blood loss was not provided, the bleeding was described as ¿major¿ and occurred near the patient¿s nipple.The patient¿s cause of death was hemorrhage.An autopsy was not performed.The subject device was discarded by the facility.

• Brand Name: SINGLE USE 3-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: 18689317
• Report Number: 9614641-2024-00347
• Device Sequence Number: 17741347
• Product Code: KNS
• UDI-Device Identifier: 04953170382604
• UDI-Public: 04953170382604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: KD-V411M-0320
• Device Lot Number: 36V
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/29/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown