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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 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus (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 is received, 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, following microbes were detected from the sample collected from the all channels of the subject device. [first time: (b)(6) 2021] coagulase negative staphyloccocci (3 cfu/endoscope). [second time: (b)(6) 2021] coagulase negative staphyloccocci (3 cfu/endoscope). The subject device had been manually reprocessed using with peracetic acid. 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 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 device. The testing result cleared the (b)(6) guideline. (b)(4) checked the subject device and found that no defects or lack of conformity, therefore the subject device sent back to the user without any repair. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined. 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 192-8 507
JA 192-8507
MDR Report Key12392312
MDR Text Key280709400
Report Number8010047-2021-11024
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K181451
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 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2021
Is This a Reprocessed and Reused Single-Use Device? No

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