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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for evaluation. The evaluation confirmed the reported event as a visual inspection was performed and the bending section skeleton was found broken; located approximately 75mm from the distal end side. The bending section cover was received separated (torn) from the glue on the insertion tube side, exposing the broken bending section skeleton. The bending section skeleton is fully broken with sharp edges adjacent to the insertion tube. The bending section tab was lifting at the same location. A review of the scope's instrument history record showed the scope was purchased on (b)(6) 2018 and was last serviced by olympus on (b)(6) 2018. Based on similar reports related to the reported event and reported device, the likely cause of the could be attributed to the operator¿s technique. The instruction manual states the following; ¿do not twist or bend the bending section with your hands. Equipment damage may result¿. Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment. Limited information was provided by the user facility. As part of our investigation, multiple follow ups were made in telephone and in writing to obtain additional information regarding the reported event but no information was obtained. However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
Olympus was informed that the bending section was broken. There was no patient involvement reported with the subject 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
4089355124
MDR Report Key8346361
MDR Text Key137254764
Report Number2951238-2019-00438
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
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 Manufacturer01/24/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2019
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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