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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
The customer reported to olympus, the uretero-reno videoscope was leaking during reprocessing. Another uretero-reno videoscope was used to complete the following procedure. During the inspection of the returned device, the cable support was broken and protruding from the bending section cover. There were no reports of patient harm associated with this event. This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
 
Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed. The device was leaking around the rubber on the distal end. The cable support was broken and protruding from the bending section cover. The raised part of the cable support caused a perforation of the bending section rubber cover, which had caused the leak. In addition, a case on the scope was slightly scratched. The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. It has been over 3 years since the subject device was manufactured. Based on the results of the investigation, it is likely an excessive force was applied to the bending section, which damaged the bending tube. A definitive root cause cannot be identified. Olympus will continue to monitor the field performance of 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 Key13049359
MDR Text Key286467831
Report Number8010047-2021-16464
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
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 Manufacturer11/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2018
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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