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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS / OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS CORPORATION OF THE AMERICAS / OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number URF-V2-W
Device Problems Break (1069); Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
Event Type  malfunction  
Event Description
Md was using 200 micron laser fiber in ureteroscope, and fiber did not fit correctly. Md changed to 365 micron fiber when lasering in other ureter, and small piece of fiber broke off, possibly due to scope. Retrieval of fragment was attempted: md was able to get fragment into basket, but piece fell out during removal. Md attempted to find fiber fragment, but was unable. Fda safety report id# (b)(4).
 
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Brand NameOLYMPUS URETEROSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS / OLYMPUS MEDICAL SYSTEMS CORPORATION
MDR Report Key10447973
MDR Text Key204351684
Report NumberMW5096215
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2-W
Device Lot NumberKR933656
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
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