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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 Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Date 08/28/2020
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to the user facility.The fse replaced the grey connector.The device was tested to make sure no fluid was leaking.The device was repaired according to regulations.The cause was traced to the user swinging the scope connector/tube to the side after is removed from the scope.This causes the top of the grey connectors to loosen.No other issues were reported.If additional information is obtained, a supplemental report will be filed.
 
Event Description
A user facility reported that the top of a grey connector came loose.No patient involvement or injuries were reported.No additional information has been obtained.
 
Manufacturer Narrative
The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿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.¿ the root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the connector unit was broken for the connector was loosen or broken, which led to connecting tube not possible to be connected.The breakage of the connector may have been due to stress, being added to the connector by the user handling, and the accumulated stress toward loose direction.We could not confirm any factor to cause the event from design nor structure of the 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
MDR Report Key10567445
MDR Text Key207965910
Report Number8010047-2020-06730
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 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
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 Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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