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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-P6R
Device Problem Material Puncture/Hole (1504)
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 on the received device and noted the distal end is broken. The distal end is broken at about 5mm from the base of the bending section area exposing metal. During the inspection there is sufficient evidence of metal protruding outside the bending section cover with no sharp edge. The elements inside the bending section are still connected together regardless of the broken skeleton. The bending section cover was removed and did not find any other sharp edges on the bending section skeleton. The distal end was inspected further and noted that the bending section cover glue is third party. The leak test cannot be performed due to the broken bending section. 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. Inspect the device for kinks, buckles, and missing parts. Should any abnormality be found. Do not use and contact an authorized olympus representative. ¿ the scope was purchased on october 16, 2016 with no previous repair history.
 
Event Description
The service center was informed that during reprocessing a hole was noted on the tip of the scope. There was no patient injury reported. No further information was provided.
 
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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 Key8870224
MDR Text Key217975549
Report Number8010047-2019-02887
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2019
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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