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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 Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed during the incoming inspection for repair at the service department of olympus (b)(4) (oaz), it was found that the bending section cover of the subject device had been torn and the broken internal metal part had been sticking out from the inside of bending section cover of the subject device. There was no report of patient injury associated with this event.
 
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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 Key11024983
MDR Text Key227146933
Report Number8010047-2020-10520
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2019
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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