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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-V
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to sorc but has not been returned to omsc. Sorc checked the subject device for evaluation. It was confirmed that the insertion tube of the subject device was peeled off more than 4mm due to the deterioration. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. It could not be identified the cause of the reported phenomenon. However based on the report of sorc, omsc surmised there was the possibility this phenomenon was attributed to deterioration of the insertion part serpentine tube of the subject device. In addition, it has been confirmed that this phenomenon does not occur due to product or manufacturing, and that there is no problem with safety and there are no multiple occurrences. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection at olympus service operation repair center (sorc), it was found that the insertion tube of the subject device was peeled off more than 4mm. The occurrence date of the event is unknown. There was no report of patient injury associated with the 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
MDR Report Key12566388
MDR Text Key280928656
Report Number8010047-2021-12590
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

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