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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-V2
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received for evaluation. Evaluation determined that the device lg (lens guide) tube was found burned. Multiple parts of the device were determined to be non olympus including the insertion tube unit. The identified parts were replaced, device was repaired. Once completed, the device was tested and passed all required testing and specifications. Based on evaluation findings, the reported issue was attributed to use error, device maintenance and handling issue. Once defective parts were replaced and device repaired, the issue was resolved.
 
Event Description
It was reported that the scope melted during reprocessing. According to the reporter, the scope was put in the autoclave melted and further site investigation found out that the scope per the users ifu (instruction for use) and manual, should not be placed for autoclaving. There was no patient involvement on this report. No user harm or injury was reported.
 
Manufacturer Narrative
This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion. 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. The ifu (instruction for use) contains warnings for third-party repairs as follows: 5. 4 returning the endoscope for repair: olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-olympus personnel. The instruction manual contains a warning about applying autoclaving to the subject device with the following contents. 3. 6 steam sterilization (autoclaving): do not steam sterilize the endoscope. Steam sterilization will cause severe damage. From the above, it is probable that the customer's handling of the device deviated from the ifu. Olympus will continue to monitor complaints for this device.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-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 Key10290933
MDR Text Key223496403
Report Number8010047-2020-04535
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
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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