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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematuria (2558)
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc) for evaluation. Omsc could not review the service and manufacturing record (dhr) because the serial number was not described on the literatures. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
On april 2nd, 2019, olympus medical systems corp. (omsc) received a literature titled ¿treatment of renal stones with retrograde intrarenal surgery in a regional hospital¿. The literature reported that seventy procedures of the retrograde intrarenal surgery (rirs) were conducted using a non-olympus ureterorenoscope (richard wolf (b)(4)) or an olympus ureterorenoscope (urf-p5) with the unspecified ureteral access sheath (10/12 fr or 12/14 fr). Renal ultrasound and kidney, ureter and bladder (kub) were conducted in all patients fifteen and thirty days after rirs for hydronephrosis and residual fragments. Rirs in case of the kidney or rigid ureterorenoscopy in the case of the ureter were conducted for residual fragments. The literatures reported that complications occurred as follows; early abortion of the procedure due to gross hematuria: one case. Fever: seven cases. It was reported that all of the reported complications were not serious injury. The literature concluded that rirs is safe and effective treatment. Further detailed information such as the relationship between the subject device and all of the reported complications could not been obtained at present. Therefore, according to the number of the type of complications known and the number of olympus device used for procedure, omsc is submitting two medical device reports. This is a report on early abortion of the procedure due to gross hematuria and one of two reports.
 
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Brand NameOES URETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key8547993
MDR Text Key143259871
Report Number8010047-2019-01837
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2019
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
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/25/2019 Patient Sequence Number: 1
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