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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 Failure to Cycle (1142)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was on site to evaluate the reported issue.No issues were found with the device during the inspection.All the sensors were working correctly without errors during the test cycle.The fse worked with the customer through a complete cycle to reset the machine.The chemicals loaded and drained without further issues.No repair on the device was needed.If additional information is obtained a supplemental report will be filed.
 
Event Description
A user facility reported that the cycle counter on an endoscope reprocessor oer-pro was not resetting.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 root cause could not be conclusively determined.Probable causes that could have led to the reported event include that draining disinfectant process was interrupted which led to disinfectant cycle counter not reset.
 
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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 Key10784464
MDR Text Key224477582
Report Number8010047-2020-08521
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/11/2020
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-PRO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/07/2020
Initial Date FDA Received11/04/2020
Supplement Dates Manufacturer Received12/02/2020
Supplement Dates FDA Received12/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2019
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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