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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 Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair of the subject device at the olympus service operation repair center (sorc), it was found that the angulation at the bending section was locked and could not be released. The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device was returned to olympus service operation repair center (sorc). Sorc checked the subject device and found the reported phenomenon, also found that the angulation lock was caused by deterioration of the angulation mechanism by rust. The exact cause has been under investigation. Therefore, the exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. The subject device was returned to olympus service operation repair center (sorc). Olympus medical systems corp. (omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based upon the information from sorc, omsc surmised that this phenomenon was attributed to an excessive twisting operation to the left or right direction with the angulation of the bending section locked, or an irregular mechanical stress such as sudden angulation. If additional information is received, this report will be supplemented.
 
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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 Key13203603
MDR Text Key289760872
Report Number8010047-2022-01115
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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