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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 Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for evaluation. A visual inspection was performed and noted the scope failed a leak test due to a hole on the bending section cover. In addition, the bending section skeleton was noted to be broken; however, there were no signs of metal protruding as the bending section cover was intact. Upon removal of the bending section cover, the skeleton was found detached with a cracked and sharp metal tab. The scope was serviced and returned to the user facility. Based on similar reported events and investigation findings, the cause of the broken /sharp skeleton metal tab could be attributed to the operator¿s technique. The original equipment manufacturer (oem) performed investigations related to this device issue. As a result, the oem has conducted a field corrective action including a distribution of ¿instructions for safe use¿ to mitigate the potential risk of patient injury. The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury. ¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient. If the up/down angulations control lever does not move. If the angulations control mechanism is not functioning properly. Visually inspect the bending section for no metallic parts protruding from the bending section. Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight. Visually inspect the bending section for abnormal bending shape, or other irregularities. Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation. ".
 
Event Description
Olympus was informed that during preparation for use, the scope was found damaged. There was no patient involvement with the subject scope as the scope was removed and sent for service.
 
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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 Key6965180
MDR Text Key90686107
Report Number2951238-2017-00692
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
Remedial Action Recall
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
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 Manufacturer09/28/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
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
Removal/Correction NumberZ-1251-2017

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