MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GUIDE SHEATH KIT

Model Number	K-202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during an endobronchial ultrasound-guided transbronchial needle aspiration procedure for suspected peripheral lung cancer, the ultrasonic probe was used in combination with the single-use guide sheath.Upon removal from the patient, it was observed that approximately 5cm of the probe's coating had peeled off.Ct and fluoroscopy were immediately performed to check for retained fragments, and none were detected.The procedure was completed and the patient was discharged on (b)(6) 2025.On (b)(6) 2025, the patient's condition suddenly deteriorated, requiring emergency intervention.The patient was transferred to the hospital where death was confirmed the same day.The cause of death was documented as unknown, and no additional information regarding autopsy findings or contributing factors was available.There were no reports of procedural complications, immediate post-procedural adverse events, or confirmed device-related injury.There was no reported malfunction or issue with the single-use guide sheath.
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).There was no alleged device failure.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE GUIDE SHEATH KIT
• Common Device Name: SINGLE USE GUIDE SHEATH
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21426812
• Report Number: 9614641-2025-00182
• Device Sequence Number: 20811631
• Product Code: EOQ
• UDI-Device Identifier: 04953170245480
• UDI-Public: 04953170245480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: K-202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/20/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASONIC PROBE
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown