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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Type  Injury  
Event Description
Olympus reviewed the following literature article: "determining whether previous swl for ureteric stones influences the results of ureteroscopy as the second-line treatment: a clinical study" by catalin pricop, marius ivanuta, and george daniel radavoi, et al.This study was aimed to determine whether shock wave lithotripsy (swl) is a limiting and potentially harmful first-line procedure for ureteric stones where ureteroscopy (urs) is necessary as a second-line treatment to render a stone-free status.A total of 158 patients were included in two groups (n=79 each): group a comprised patients with no swl before urs, and group b comprised patients who previously had swl.The results discussed for the urs with pneumatic lithotripsy, as a first therapeutic method, while comparing it with those of the urs after a failed swl for ureteric stones.Group a had higher stone-free rates; group b had higher rates of ureteral edema and similar intraoperative ureteral lesions.The study concluded that the failure of swl for lumbar or pelvic ureteral lithiasis does not appear to have a negative effect on the rate of intraoperative complications or the success rate of semi-rigid retrograde urs for this category of calculi, with the same safety profile as first-line endourological intervention.  the authors used  one olympus device and reported the following adverse events: 5 minor perforations in group b (olympus ureteroscope).
 
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The legal manufacturer has completed the investigation.The device history records review can not be performed since no serial number was provided.Olympus ships devices that are manufactured according to all specifications and meet final release criteria.The legal manufacturer was unable to determine the root cause of the reported event and no device malfunctioned.It is unknown what the causal relationship is between the device and the adverse event.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13543118
MDR Text Key285694318
Report Number8010047-2022-03039
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340321
UDI-Public04953170340321
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/16/2022
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? No
Device Operator Health Professional
Device Model NumberURF-V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/17/2022
Initial Date FDA Received02/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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