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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-V2R
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to the service center for evaluation. The user¿s complaint was confirmed. A visual inspection was performed on the received device and noted the bending section skeleton tab was protruding out from the bending section cover causing it to fail the leak test. The bending section cover was then removed and noted the bending section skeleton tab was fully broken/detached at the insertion tube area. Additionally, there was no significant evidence of sharp areas noted with the broken/detached skeleton. The urf-v2r instruction manual states that ¿do not twist or bend the bending section with your hands. Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damage. ¿.
 
Event Description
The service center was informed that during reprocessing, the scope¿s bending section was noted to be broken. There was no patient injury reported.
 
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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 Key9155804
MDR Text Key201876969
Report Number8010047-2019-03495
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,user f
Reporter Occupation
Type of Report Initial
Report Date 10/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2019
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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