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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus medical systems corp. For evaluation. The manufacturing record of the subject device was reviewed without irregularity related to this event. The exact cause of the event could not be concluded at this moment. If additional and significant information becomes available, this report will be supplemented.
 
Event Description
The subject device was returned to olympus (b)(4) from olympus (b)(4). (b)(4) confirmed that the bending rubber of the subject device was cut and the bending tube was cracked. It was also confirmed that the inner parts such as wires were exposed from the bending section. It is unknown when the device malfunction occurred. There was no patient injury associated with this event reported.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6772986
MDR Text Key82159674
Report Number8010047-2017-01186
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2429304-12/12/2016-041C

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