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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-PRO
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to confirm the reported issue.The fse found missing sensor covers and broken air/water/instrument channel connectors.Fse installed new covers and gray connectors.Equipment passed functional test.Equipment repaired and verified according to oem instructions.Software attributes have been verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.
 
Event Description
A user facility reported an e22 fluid pressure is insufficient error on the oer-pro endoscope reprocessor unit.There was no patient involvement or injuries reported.No additional information has been obtained.
 
Manufacturer Narrative
There is more information on the device.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.The connector may have got loosened from stress applied to the connector by the user handling, which was accumulated, or the user may have dropped some hard objects to the connector.Abnormality is detectable by inspecting the equipment in accordance with the following instructions for use (ifu).Chapter 3.Inspection before use, 3.3 inspecting the connectors check the following for each connector: the connector should be fixed firmly the o-rings should be free of abnormalities such as cracks, tears, or dents.
 
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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
MDR Report Key11368812
MDR Text Key233183992
Report Number8010047-2021-02909
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
PMA/PMN Number
K103264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-PRO
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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