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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
The customer¿s contact, occupation and health profession are unknown at this time. A review of the cds checklist showed the last culture sample was on (b)(6) 2021 and results are not available at this time and have been requested. The scope was cultured following maintenance. The customers uses aniosyme x3 detergent for cleaning, asept inmed is used for precleaning and anioxy twin is used as a disinfectant. According to the checklist, the biopsy valve, air valve, and suction valve disinfected or sterilized in accordance to the procedure manual. The returned device is pending evaluation. An investigation is ongoing to obtain additional information regarding the reported event. If additional information is received this report will be supplemented accordingly.
 
Event Description
Olympus (b)(4) was informed by the user facility that after a microbiological routine control on this videoscope, the user facility detected an unexpected contamination. The user did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause. The scope has been returned to the regional repair center for evaluation.
 
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Brand NameVIDEOSCOPE "URF-V"
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 Key12634692
MDR Text Key281071099
Report Number8010047-2021-13151
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 foreign,health professional,u
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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