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); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date was reported as the publication date of the literature.This report is related to (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus reviewed the literature titled "safety and risk factors for bleeding complications of radial probe endobronchial ultrasound-guided transbronchial biopsy." this study aimed to evaluate the diagnostic performance and complication rate of radial ebus-guided transbronchial biopsy (tbb) and investigate risk factors associated with procedure-related bleeding events.Of (b)(4) patients (median age, 69 years; men (b)(4)) included, (b)(4).The median procedure time was 22min (iqr, 15¿31min).The diagnostic accuracy, sensitivity, and specificity for malignancy were (b)(4) respectively.When the (b)(4) patients who did not undergo tbb were included, the diagnostic accuracy for malignancy was (b)(4).Type of adverse events/number of patients: event 1: bleeding (grade 2 or higher) (n=(b)(4)).Of (b)(4) with procedure-related bleeding events, (b)(4) had delphi grade 2 bleeding events, and only (b)(4) had delphi grade 3 bleeding events.Epinephrine was used in (b)(4) patients, and a balloon blocker was used in (b)(4) of them for bleeding control.Event 2: pneumonia (n=(b)(4)).No treatment information was provided.Event 3: pneumothorax (n=(b)(4)).(b)(4) patients required percutaneous catheter placements.The other patient required no intervention.Event 4: complicated pleural effusion (n=(b)(4)).No treatment information was provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received (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, it is likely that the reported event is an accident, or a complication associated with a procedure using the subject device.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
The following additional information was received from the facility: it is unknown if an olympus device cause or contribute to the adverse event described in the article, or if an olympus device malfunction during any procedure described in the article.

• 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: 20456703
• Report Number: 9614641-2024-01987
• Device Sequence Number: 7718847
• Product Code: EOQ
• UDI-Device Identifier: 04953170245466
• UDI-Public: 04953170245466
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 09/17/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOSPY FORCEPS FB-231D.; FLEXIBLE BRONCHOVIDEOSCOPE BF-260.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown