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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus and evaluated. The reported problem was confirmed. A cut/hole was observed in the a-rubber, resulting in a leak. In addition, the bending section was observed broken with metal protruding. Based on the results of the device evaluation and similar reported complaints, the most likely cause of the reported event can be attributed to user handling or technique. The device instructions for use contains the following statements: caution: "do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved. The bending section may be damaged. Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc. Do not insert the insertion tube with excessive force and twist. " "do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. " ¿do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leaks. ".
 
Event Description
A user facility reported to olympus a "tear" at the distal end of the scope. There was no patient injury or harm, associated with the problem, reported to olympus.
 
Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review. The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications. The legal manufacturer performed an investigation. Based on similar reported complaints, the legal manufacturer determined the likely cause was user handling or technique.
 
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Brand NameURETERO-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 Key10351056
MDR Text Key224633190
Report Number8010047-2020-05092
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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