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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-V3
Device Problems Break (1069); 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 both the bending section rubber and the insertion tube were damaged and the broken internal metal part had been sticking out from the inside, and also 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 phenomena (the rubber/tube breakage and the angulation lock), also found that the angulation lock was caused by the breakage of the angulation wires. 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.
 
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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 Key13086023
MDR Text Key286851302
Report Number8010047-2021-16855
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181451
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 02/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2019
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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