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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERORENOFIBERSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERORENOFIBERSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number URF-P3
Device Problem Poor Quality Image (1408)
Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144); Hematuria (2558)
Event Type  Injury  
Event Description
It is reported in the journal article titled "the effect of antiplatelet agents on bleeding related complications following ureteroscopy, " nine of 314 patients from the study group had ureteroscopy performed (while receiving anti-platelet therapy) using one of five listed scopes including an olympus urf-p3, and experienced adverse events. Of the nine patients experiencing adverse events, five patients experienced what was classified as a significant bleeding event:(1) procedure termination explicitly due to bleeding and difficult visualization resulting in a second operative intervention; (2) unplanned, immediate postoperative admission for bleeding; (3) ed visit for hematuria; (4) subsequent hospital admission for hematuria management (after dismissal home post-procedure); and 5) unplanned return to the or for evaluation of ongoing bleeding. No patient required a blood transfusion. One patient experienced a non-significant bleeding event, with no treatment required. Two patients were re-admitted post-procedure for fever/bacteremia (treatment not specified). One patient was re-admitted post procedure for abdominal pain, nausea and vomiting (treatment not specified). This is a retrospective study from 2009-2016 and there is no specific information regarding which scope was used in each case. This report is being submitted to report the potential that an olympus device could have caused or contributed to an adverse event in one of the nine patients who experienced an adverse event. There is no report that the urf-p3 malfunctioned in any way.
 
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Brand NameOES URETERORENOFIBERSCOPE
Type of DeviceURETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key11465474
MDR Text Key239269045
Report Number2951238-2021-00299
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 Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 02/14/2021,03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberURF-P3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/14/2021
Event Location No Information
Date Report to Manufacturer02/14/2021
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/11/2021 Patient Sequence Number: 1
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