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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-V
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated at sorc. As a result of the evaluation, the following was confirmed. -the watertightness was not maintained due to the tearing of the insertion tube due to external factors. -external factors damaged the grip unit, angulation control lever, universal cord, video connector, light guide connector, video connector, and up/down angulation lock. -the universal code was wrinkled. The coating on the insertion tube may have peeled off due to some external force applied to the insertion tube. However, the exact cause of the reported event could not be conclusively determined, because the device has not been returned to olympus medical systems corp. (omsc). The reported event was not attributed to the product or manufacturing, and omsc confirmed that there were no issues with device safety. Also, the reported event does not tend to occur frequently. From the device repair history, omsc confirmed that the bending section rubber, bending section, boot and rotating mechanism were replaced on (b)(6), 2021 and the insertion tube was replaced on (b)(6), 2019. Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus inspected the device at olympus service operation repair center (sorc) and found that the coating on the insertion tube was peeled off by more than 4 mm at maximum width. 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
MDR Report Key12558942
MDR Text Key281393224
Report Number8010047-2021-12535
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 10/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No

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