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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V3
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The referenced scope was returned to the manufacturer for evaluation. A visual inspection was performed on the scope; there was an irregular shape on the bending section at the distal end. The irregular shape on the bending section appears both in the neutral and up angulated positions. When engaging the control lever the movement of the bending section is abnormal in the up direction; down angulation has no response while attempting to manipulate the lever. A microscope inspection was performed on the skeleton of the bending section and discovered that some of the cable supports have detached from the up and down angle wires or partially detached from the wires. The cable support pins that have receded and become detached (partial and full) from the angle wire have caused the bending section to become an irregular shape. The damage to the cable support pins can potentially occur if excessive force is used to manipulate the bending section whenever it becomes stalled. The scope was leaking from the biopsy channel. An olympus boroscope was then used to inspect the biopsy channel and found multiple tear marks at the opening of the channel from the distal end side at approximately 20 mm. The scope was purchased on (b)(6) 2019 accumulating seven uses since. The cause of the reported event could not be determined at this time. The scope will be forwarded to the original equipment manufacturer (oem) for further investigation.
 
Event Description
During an in-service conducted by the manufacturer, it was determined that the distal tip of the scope was damaged as the up angulation was not working. There was no patient involvement with the subject scope as the scope was removed and sent for service. It was reported that the customer received the instruction for safe use manual.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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 Key8680235
MDR Text Key147644920
Report Number2951238-2019-00920
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2019
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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