MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 06/26/2023

Event Type  Injury  

Event Description

Olympus reviewed the literature article titled, "safety and feasibility of ultrathin probe transbronchial lung cryobiopsy without balloon blocker via robotic bronchoscopy in the evaluation of peripheral lung lesions: a retrospective pilot study" to date, there is controversy regarding unilateral versus bilateral stent placement in patients with malignant hilar biliary strictures (mhbss).The aim of this study was to compare the clinical outcomes and complications of unilateral and bilateral (stent-in-stent method) stent placements for these patients.Complications/number of patients bleeds 4 pneumothorax 3 three incidents of pneumothorax occurred.All required interventions.One was discharged on the same day without small-bore chest tube (sbct) after successful manual aspiration; one was discharged with sbct for ambulatory management; and one was hospitalized with sbct after failing manual aspiration.Both chest tubes were removed within 72 h.Four grade 2 bleeds occurred based on the nashville bleeding scale, meaning that one or more tools were required to control or prevent further bleeding, i.E.Suctioning >1 min required or repeat wedging of the bronchoscope for persistent bleeding or instillation of cold saline, diluted vasoactive substances or thrombin.This literature article requires 2 reports.The related patient identifiers are as follows: (b)(6) - um-s20-17s (b)(6) - bf-mp190f this medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00228.Since the literature described olympus device used for radial probe endobronchial ultrasonography (pr-ebus), olympus selected bf-mp190f and um-s20-17s as a representative products.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 event 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: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17373097
• MDR Text Key: 319568303
• Report Number: 3002808148-2023-07376
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

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
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BF-MP190F
• Patient Outcome(s): Required Intervention; Hospitalization