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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-V2R
Device Problem Bent (1059)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for evaluation. The evaluation confirmed that reported device damage. The bending section and angulation were found damaged. The scope was serviced and returned to the user facility. Based on the evaluation findings, the cause of the reported scope damage is likely attributed to the operator¿s technique / excessive force. The instruction manual for use states, ¿to prevent damage, do not apply excessive force to the endoscope and accessories during reprocessing. Do not attempt to bend or twist the endoscope¿s insertion section with excessive force. The insertion section may be damaged. ¿.
 
Event Description
Olympus was informed that during reprocessing, it was noted that there was a bend (kink) above the metal near the tip of 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 Key6415643
MDR Text Key70327708
Report Number2951238-2017-00167
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 03/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Device Catalogue NumberURF-V2R
Device Lot NumberN/A
Other Device ID Number04953170343612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
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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