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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 Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
As part of our investigation, olympus made multiple follow up attempts with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The scope was returned to olympus for evaluation. The evaluation found the bending section in critical condition. The bending section cover was found with a hole/cut and the bending section skeleton ribs were found broken. The scope was serviced and returned to the user facility. Based on similar reported events and investigation findings, the cause of the protruding / lifting 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 angulation control lever does not move. If the angulation 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. " if additional information becomes available at a later time, this report will be supplemented accordingly.
 
Event Description
Olympus was informed that during an unspecified procedure, the scope¿s bending section broke. There was no patient injury reported.
 
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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 Key7463113
MDR Text Key107101584
Report Number2951238-2018-00275
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK072957
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 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Device Catalogue NumberURF-P6R
Device Lot NumberN/A
Other Device ID Number04953170340833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
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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