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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 Type  malfunction  
Manufacturer Narrative
Device was returned for evaluation. The returned urf-v2r scope (serial #: (b)(4) ) was evaluated due to reported ¿protruded broken skeleton¿. Investigation noted that the user¿s complaint was confirmed. Visual inspection was performed on received condition and determined that the distal end is broken. It was broken at the base of the bending section area exposing metal. During inspection it was determined that there was sufficient evidence of metal protruding outside the bending section cover however, there was no sharp edge noted. In addition, during the investigation, it was determined that the elements inside the bending section are still connected together regardless of the broken skeleton. The bending section cover was removed and there were no findings of any other sharp edges on the bending section skeleton. According to the instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿. The bending section was manipulated; the movement is abnormal due to the broken skeleton. The scope was purchased on (b)(6) 2018 and the last time the scope came in for service was (b)(6) 2019 for a 28f refurbishment. The leak test cannot be performed due to the broken bending section. Based on the evaluation, the likely cause of the reported issue of protruded broken skeleton is due to excessive force which is attributed to mishandling.
 
Event Description
The user facility reported an issue regarding a protruded broken skeleton of a urf-v2r scope. The device was not used during a patient procedure. It was reported that the issue was discovered during reprocessing testing of the scope. It is unknown who was operating the device during observation. No user impact or 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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9135401
MDR Text Key214612525
Report Number8010047-2019-03418
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
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 Manufacturer09/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2019
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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