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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number OLYMPUS URF TYPE V
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2016
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to (b)(4) factory for evaluation. When the subject device was connected to a video system center at (b)(4) factory, the reported phenomenon was not reproduced. As a result of confirmation of the channel inside of the subject device, some pinholes were found at the place of around 40mm from the distal end and air leakage occurred from the pinholes. From the above, it is considered that this phenomenon might occur because moisture and water were invaded from the pinholes in the channel and the internal circuit of ccd unit temporarily short-circuited. It is considered that the short of the internal circuit of the ccd unit was caused by the insufficient maintenance of the subject device by the user facility, which had continued using such device with air leakage.
 
Event Description
Olympus medical systems corp(omsc) was informed that the endoscopic image disappeared at the end of flexible transurethral lithotomy with the subject device. The procedure was completed with the use of another spare device. There was no patient injury reported.
 
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Brand NameOLYMPUS
Type of DeviceURETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachiouji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
nishina susumu
2951 ishikawa-cho,
hachioji-shi, tokyo 192-8-507
JA   192-8507
6425177
MDR Report Key6147119
MDR Text Key61504888
Report Number8010047-2016-01517
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOLYMPUS URF TYPE V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
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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