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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P7
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2022
Event Type  malfunction  
Event Description
The customer reported to olympus, during routine testing, the endoscope tested positive for microbial contamination.All channels were sampled and 5 colony forming units of aerobic microorganism bacterium were detected.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
 
Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The physical device evaluation has not yet been completed.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.The suspect device has been returned to olympus for evaluation and the investigation is in process.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufactures review of the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's final investigation.The legal manufacture reviewed the provided facility cds practices of the subject device where no deviations from the device instructions for use (ifu) were noted.The device was evaluated where no abnormalities were found that could have led to the positive culture.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with ifu before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.
 
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Brand Name
URETERO-RENO FIBERSCOPE
Type of Device
URETERO-RENO FIBERSCOPE
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 Key14754550
MDR Text Key302583606
Report Number8010047-2022-10419
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403811
UDI-Public04953170403811
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/22/2022
Initial Date FDA Received06/21/2022
Supplement Dates Manufacturer Received08/19/2022
Supplement Dates FDA Received09/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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