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

Model Number	K-201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The author was not reachable to obtain any further information.The investigation is ongoing, and this report will be supplemented when new and relevant information becomes available later.
Event or Problem Description
Olympus reviewed the following literature titled "performance of radial endobronchial ultrasound for peripheral pulmonary lesions without automation technology in tuberculous endemic region: real-world experience in a single institution over 6 years." this is a retrospective chart review of all adult patients undergoing radial endobronchial ultrasound (rebus)-guided transbronchial biopsy for peripheral pulmonary lesions (ppl) in our institution over 6 years duration (october 2016 to december 2022).Various flexible conventional (bf-h190), thin bronchoscopes (bf-mp190-f), radial ebus probes (k-201) and an endobronchial balloon (b5-2c) were used for the procedures.During the study period, a total of 558 procedures were performed.Seven cases were excluded due to the presence of visible endobronchial lesions during initial scouting bronchoscopy.The final number of procedures available for analysis was 551.Pneumothoraxes: 1.1% - requiring percutaneous drainage.Mild bleeding: 22.1%.Moderate bleeding: 5.3%.
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, 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.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18751496
• Report Number: 9614641-2024-00439
• Device Sequence Number: 11694678
• Product Code: EOQ
• UDI-Device Identifier: 04953170245466
• UDI-Public: 04953170245466
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K060243
• 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): 04/09/2024

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: K-201
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/09/2024
• 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: B5-2C; BF-H190; BF-MP190F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown