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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/16/2016
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The evaluation found the scope to have an abnormal bending section during angulations. The evaluation found the skeleton of the device broken at the bending section on the insertion tube side. Based on the oem investigation findings from previous reports, the device damage can be attributed to excessive torque loaded to the bending section during usage and user handling. The instruction manual warns user "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. ".
 
Event Description
The user facility reported that it is believed that the scope was broken in transit from the or to the reprocessing room due to mishandling. There was no metal exposed; the scope was just flimsy. It was reported that the device had been used in a procedure without issue.
 
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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 Key6251309
MDR Text Key64912419
Report Number2951238-2017-00016
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 01/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Device Catalogue NumberURF-V2
Other Device ID Number04953170343582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2016
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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