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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 Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. Evaluation of the device confirmed the reported issue of hole on the distal end of the scope. The a rubber was found leaking and a protruding metal was found on the bending section. In addition, an excessive breakage on the ig (image generator) of the device was observed. The identified parts were replaced, device was repaired. Once completed, the device was tested and passed required testing and specifications.
 
Event Description
It was reported that during preparation for use, the device was found to have hole on the distal end. The device was leaking due to the hole observed. There was no patient involvement on this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the review of the device history records (dhr). Please see updated sections. The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria. No abnormalities were found. A probable cause of the reported issue likely due to bending tube kinked occurred during use, an excessive force was applied. As stated on the ifu and as a preventive measure, the user manual states : 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 maybe 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. Olympus will continue to monitor complaints for this device.
 
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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 Key10184252
MDR Text Key223476431
Report Number8010047-2020-03576
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2020
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 Manufacturer06/01/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2018
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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