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U.S. Department of Health and Human Services

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

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SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE Back to Search Results
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.¿.
 
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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 Key17373207
MDR Text Key319669523
Report Number2429304-2023-00228
Device Sequence Number1
Product Code ITX
UDI-Device Identifier04953170368479
UDI-Public04953170368479
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberUM-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 Date06/26/2023
Event Location Hospital
Date Report to Manufacturer06/26/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BF-MP190F
Patient Outcome(s) Hospitalization; Required Intervention;
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