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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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. The exact cause of this event could not be conclusively determined. Olympus medical systems corp. (omsc) surmised that the reported phenomenon occurred due to the following causes. The bending section of the subject device was broken due to excessive force applied to the bending section. When the bending section of the subject device was fixed, the bending section of the subject device was twisted by an excessive force. When the bending section of the subject device was fixed, the bending section of the subject device was bent sharply by an excessive force.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on (b)(6) 2021,it was found that the internal metal wire had been broken and exposed from the bending section of subject device since the bending tube sheath was broken. Other detailed information was not provided. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The subject device was returned to olympus service operation repair center (sorc). A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
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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 Key13091896
MDR Text Key286963088
Report Number8010047-2021-16904
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 01/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
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 Manufacturer12/07/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2019
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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