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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-V2
Device Problems Break (1069); Nonstandard Device (1420)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The referenced scope was returned to olympus for evaluation. A visual inspection was performed on the received scope and confirmed a broken bending section near the insertion tube side. The bending cover has partially torn at the broken bending section rib. There was a slight bend on the bending section rib that is lifted away from the bending section. The light guide bundle, sheath, ccd unit cover sheath have damaged at the same location of the broken bending section. There was no evidence of fluid in the bending section. The scope does not seem to have been used by the customer. The scope was shipped to the user facility on october 10, 2018 and the user facility reported the bending section damage on october 11, 2018. A review of the instrument history shows the scope was last in for service on (b)(6) 2018. The cause of the reported event could not be confirmed, however, olympus will continue to investigate. If additional information becomes available, this report will be updated accordingly.
 
Event Description
Olympus was informed that upon receipt of the loaner scope, the bending section at the distal end was observed to be damaged upon opening the box. There was no patient involvement with the reported scope.
 
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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 Key8044800
MDR Text Key128608305
Report Number2951238-2018-00672
Device Sequence Number0
Product Code FGB
Reporter Country CodeUS
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Device Catalogue NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1251-2017

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