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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-P7
Device Problems Mechanical Problem (1384); Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus europa k. G (oekg) for evaluation. In the evaluation, oekg confirmed the followings; - the fibers for transmitting image were broken. - the bending section was broken and the cable supports of the bending tube were detached. - the venting connector was loose. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that the angulation of the subject device was broken and some black dots appeared on the endoscopic image of the subject device during an unspecified therapeutic procedure. The procedure was aborted and rescheduled. There was no report of patient injury associated with the event.
 
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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 Key8820671
MDR Text Key152232087
Report Number8010047-2019-02674
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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