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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
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 (b)(4). (b)(4) checked the subject device and found that the reported phenomenon was caused by the insufficient reprocessing by the user. 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 during the incoming inspection for repair at olympus (b)(4), it was found that there was a foreign material in the instrument channel. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the subject device evaluation result. The subject device was not returned to olympus medical systems corp. (omsc) for evaluation but was returned to olympus (b)(4). 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, because following reasons. The composition of the foreign matter was unknown. Omsc was unable to perform a component analysis because the foreign material was not returned to omsc. This event was unusual because there was no similar event. Omsc surmised that the origin of the foreign material was followings. A part of an endo therapy accessory of the third-party that was used in the procedure at the user facility. A solidified chemicals that was used by the user in a procedure / reprocessing.
 
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Brand NameVIDEOSCOPE "URF-V"
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 Key11758493
MDR Text Key274614558
Report Number8010047-2021-05713
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2014
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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