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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 Problems Break (1069); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation. A visual inspection on the received condition was performed and noted the distal end is broken. The distal end is broken from the base of the bending section area exposing metal. During inspection there is sufficient evidence of metal protruding outside the bending section cover. Based on the evaluation and the cause of the broken bending section skeleton is most likely due to the application of excessive force, which is related to user mishandling of the device. The scope was purchased on (b)(6) 2013 and the last time the scope came in for service was (b)(6) 2019 according to the instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿.
 
Event Description
The returned scope has a broken skeleton that is protruding and there is a cut in the a-rubber. There was no patient injury or adverse outcome reported as a result of the issue.
 
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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 Key8967520
MDR Text Key213701869
Report Number8010047-2019-03203
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 09/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/05/2019
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 Manufacturer08/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/08/2019
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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