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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 Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation but was returned to (b)(4). The evaluation is in progress currently. 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 that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device. -instrument channel: coagulase-negative staphylococci (3 cfu/endoscope) other detailed information such as the reprocessing method was not provided. There was no report of infection associated with this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus (b)(4). (b)(4) sent the device to a third party laboratory for microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the all channels of the subject device. The testing result cleared the (b)(6) guideline. (b)(4) checked the subject device and there was no abnormality of the subject device. 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 the reported event could not be conclusively determined.
 
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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 Key12055249
MDR Text Key280584364
Report Number8010047-2021-07908
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
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 Manufacturer06/14/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No

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