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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 Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to the service center for evaluation. A visual inspection was performed and noted the distal end was broken at approximately 5mm from the base of the bending section exposing metal with no sharp edges. Further inspection noted the elements inside the bending section are still connected. The leak test cannot be performed due to the breakage. A review of the instrument history showed the scope was purchased on may 28, 2018 and was previously returned for service on july 8, 2019 due to damage. Based on the evaluation, the cause of the broken bending section skeleton and exposed metal are due to excessive force and mishandling. According to the instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿. The bending section was manipulated; the movement is abnormal due to the broken skeleton at the base of the bending section.
 
Event Description
The service center was informed that during reprocessing, the scope failed leak testing. The user facility¿s reprocessing technician was unsure as to when the damage occurred. There was no patient involvement reported. No further information was provided.
 
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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 Key8895500
MDR Text Key217462626
Report Number8010047-2019-02944
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
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 Manufacturer07/18/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2019
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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