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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 has not been returned to omsc for evaluation but was returned to olympus service operation repair center (sorc). Sorc checked the subject device and found that while the cleaning brush was passed through the channel of the subject device, black foreign objects adhered to the cleaning brush. 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. However, based upon the information from sorc, there was possibility that this event was attributed to the insufficient reprocessing of the subject device and/or the user handling. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user facility that during the inspection before use at the user facility, it was found that black foreign objects came out from the channel of the subject device. There was no report of patient injury associated with this 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 Key11617015
MDR Text Key249035305
Report Number8010047-2021-04617
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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 Received03/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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