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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 Problem Material Too Rigid or Stiff (1544)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for evaluation. The evaluation confirmed the reported device issue. The control knob (a-lever) was stuck causing the bending section to not bend properly. A visual inspection was performed and found the bending section broken at the insertion tube side. A hole was also found on the bending section cover. The bending section cover was removed and found two contact pins lifting from the bending section skeleton. In addition, there was heavy corrosion found on the bending section skeleton and control body section. The scope was serviced and returned to the user facility. Based on the evaluation results and similar reported events, the cause of the bending section damage is likely attributed to user handling. The instruction manual for use provides warning and caution statements in an effort to prevent scope damage. ¿do not attempt to bend or twist the endoscope¿s insertion section with excessive force. The insertion section may be damaged. Using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage. ¿.
 
Event Description
Olympus was informed that during receipt for inspection, the bending section will not bend. There was no patient involvement with the 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
408935-512
MDR Report Key6652443
MDR Text Key77939842
Report Number2951238-2017-00421
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 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Device Catalogue NumberURF-V2
Device Lot NumberN/A
Other Device ID Number04953170343582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
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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