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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-P6
Device Problems Thermal Decomposition of Device (1071); Material Protrusion/Extrusion (2979)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for evaluation. The evaluation found the scope¿s bending section metal rib broken. In addition, the bending section rubber glue was found in critical condition. There was also a leak noted on the distal end of the scope. The scope was serviced and returned to the user facility. Based on similar reported events, the cause of the reported scope damage is likely attributed to user handling. The instruction manual for use provides warning and caution statements in an effort to prevent scope breakage. ¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force. The insertion section may be damaged. Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage. ¿.
 
Event Description
Olympus was informed that a laser burnt the tip of the scope during preparation for use. Olympus inspected the scope on 5/17/2017 and found the bending section rib broken. There was no patient involvement with the scope.
 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key6632299
MDR Text Key77626320
Report Number2951238-2017-00401
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Device Catalogue NumberURF-P6
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
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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