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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 Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation. Omsc reviewed the manufacture history of the device and confirmed no irregularity. 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 microbiological testing by the user facility, the sample collected from the subject device tested positive for staphylococcus non aureus(12cfu/endoscope). The device had been manually reprocessed using peracetic acid. The user facility reported that this device was reprocessed according to the instruction manual. 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 subject device to a third party laboratory for microbiological testing. As a result of the testing, the sample collected from all channels of the subject device tested positive for bacillus spp mesophiles (1cfu/100ml) and staphyloccocus coagulase negative (1cfu/100ml). The testing result cleared the (b)(4) guideline. 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.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7854513
MDR Text Key119798342
Report Number8010047-2018-01747
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
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 09/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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