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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4). Olympus (b)(4) checked the subject device and found that the reported phenomenon could not be duplicated. Also, olympus (b)(4) found the leakage of the instrument channel. Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based on the information from olympus (b)(4), there was the possibility that this phenomenon was attributed to the following mechanism. 1. The water invaded into the subject device from the leakage point. 2. The metal in the subject device was corroded. 3. The water and the corroded material were mixed and invaded to the perforated area on the instrument channel. 4. The mixed material fell off from the instrument channel outlet.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user that during an unspecified procedure, it was found that unspecified liquid fell off from the channel. There was no report of patient injury associated with the event.
 
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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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key11427492
MDR Text Key240097831
Report Number8010047-2021-03396
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K172246
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 03/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2021
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? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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