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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus trading ((b)(4)) limited ((b)(4)). The primary evaluation of the subject device by (b)(4) confirmed following. There were leak; a part of the instrument channel near the distal end melted and there was a hole. The exact cause could not be determined at present, because the evaluation is in progress. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity. If significant additional information is received, this report will be supplemented.
 
Event Description
Olympus was informed that endoscopic image of the subject device became unclear during an f-tul (transurethral ureterolithotripsy) procedure with a laser. The subject device was replaced with another similar device and the procedure was completed. There was no patient injury report.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7624174
MDR Text Key112567973
Report Number8010047-2018-01187
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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