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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the subject device was not returned to omsc, the exact cause was unknown.Omsc surmised that the reported phenomenon occurred since the angle mechanism of the subject device was corroded due to the air leak of the subject device.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on (b)(6) 2021, it was found that the angulation of the subject device was locked due to corrosion of the angle mechanism of the subject device.Other detailed information was not provided.There was no report of patient injury associated with the event.This device is an olympus asset.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12473015
MDR Text Key280875279
Report Number8010047-2021-11729
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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