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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 Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected and leakage was found at the biopsy channel and bending rubber.The angulation wire was also found to be broken.The cause cannot be conclusively determined.
 
Event Description
It was reported the patient experienced an injury following a procedure involving the manufacturer's ureteroscope in (b)(6) of 2013.Additional information has been requested but not yet received.
 
Manufacturer Narrative
This report is being supplemented to provide additional information (h10) and corrected data (d10) regarding the reported event.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.
 
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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 Key10081256
MDR Text Key191805785
Report Number8010047-2020-02853
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 foreign,other
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2013
Was the Report Sent to FDA? No
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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