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 c23311760.¿ there is no report of any olympus device malfunction in any procedure described in this study.¿.

• 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
• MDR Report Key: 17373207
• MDR Text Key: 319669523
• Report Number: 2429304-2023-00228
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2023,07/21/2023

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?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BF-MP190F
• Patient Outcome(s): Hospitalization; Required Intervention