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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to the manufacturer for service/evaluation. A visual inspection was performed by the service group and noted the bending section at the distal end of the scope was broken and the bending section skeleton was protruding. The scope failed the leak test from the hole on the bending section cover. In addition, there were excessive broken image guide fibers noted on the image. The scope was last serviced on (b)(6) 2019. The scope was repaired and returned to the user facility. Based on the reported condition and the analysis of the device, the cause of the broken bending section skeleton and broken fibers is most likely due to excessive force and/or stress attributed to user mishandling attributed to the (unintended) operator's technique. The instruction manual warns users "do not twist or bend the bending section with your hands. Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. " 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. " based on the reported condition and the analysis of the device, the cause of the broken bending section skeleton is most likely due to excessive force and/or stress attributed to user mishandling. If additional information becomes available a supplemental report will be filed.
 
Event Description
The user facility reported the fibers were broken in the bending section and the scope has a perforated a-rubber. There was no patient harm or medical intervention reported as a result of this event.
 
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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 Key8956563
MDR Text Key216708949
Report Number8010047-2019-03170
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 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/06/2019
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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