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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

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OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-AW
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc but was returned to oth for evaluation.Oth checked the subject device and found that the reported phenomenon was duplicated.Oth removed the stain from the subject device and cleaned the subject device.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 from the user facility that during unspecified timing, the expiration of the disinfectant solution of the subject device failed on 25 cycle to 30 cycle.Therefore the field service engineer (fse) of olympus thailand (oth) visited to the facility.The fse checked the subject device and found that there was very dirty stain on the reprocessing basin.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely the inner surface of the hoses installed in the subject equipment became microscopic by deterioration from long time use.Then, the surface may have peeled off and came out as black material during reprocessing.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
 
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Brand Name
ENDOSCOPE REPROCESSOR
Type of Device
ENDOSCOPE REPROCESSOR
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 Key12064163
MDR Text Key279260055
Report Number8010047-2021-07942
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-AW
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/31/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received06/13/2022
Supplement Dates FDA Received06/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2012
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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