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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 12/22/2016
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The evaluation found the bending section skeleton broken with metal exposed and protruding through the bending section cover. The bending section cover was removed and found the bending section skeleton broken below the insertion tube side. The scope failed the leak test due to the cut on the bending section. The cause of the of the broken skeleton could not be determined as there was no signs of indentation on the bending section skeleton; however, 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 the scope was damaged during reprocessing. There was no patient involvement; therefore, no patient injury was reported.
 
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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 Key6302558
MDR Text Key66549511
Report Number2951238-2017-00066
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 02/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
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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