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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 Problems Leak/Splash (1354); Material Puncture/Hole (1504); Material Too Rigid or Stiff (1544)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
It was reported that during a procedure, the device was too stiff and caused trauma.Although requested, additional information has not been provided.The device was returned to olympus for evaluation.The device was visually inspected and the event of too stiff could not be duplicated.Additionally, pinholes and leaking were found at the insertion tube.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.
 
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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 Key10312338
MDR Text Key200043441
Report Number2951238-2020-00481
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2020,07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/30/2020
Event Location Hospital
Date Report to Manufacturer06/30/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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