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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

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OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-4
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned toolympus medical systems corp.(omsc) for evaluation.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
The user noticed that the air filter and water filter of the subject device have never been replaced for 2 years.There was a possibility of insufficient cleaning of the subject device.There were no reports of patient injuries related to this incident.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.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.However, omsc surmised that this phenomenon is attributed to the inappropriate handling by the user.If additional information becomes available, this report will be supplemented.
 
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Brand Name
OER-4 100V
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
MDR Report Key10210459
MDR Text Key223480973
Report Number8010047-2020-03735
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberOER-4
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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