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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 Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Date 01/19/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus technical support engineer helped the customer to troubleshoot the reported issue.During the troubleshooting, the customer was able to conduct a drain and load lcg to load the new acecide-c, high level disinfectant, into the oer-pro.No other issues were reported.If additional information is obtained a supplemental report will be filed.
 
Event Description
A user facility reported that they closed the disinfectant drawer without loading the acecide-c containers and they were unable to reopen the drawer.There was no patient involvement or injuries reported.No additional information has been obtained.
 
Manufacturer Narrative
This report is being submitted to provide additional information from the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) was conducted.The dhr review did not find any anomalies or abnormalities identified during production.The device met all specifications upon release.The root cause was linked to user handling.The user closed the disinfectant drawer without loading the disinfectant bottle.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
MDR Report Key11332951
MDR Text Key233369504
Report Number8010047-2021-02682
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 04/14/2021
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? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/19/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/26/2021
Supplement Dates FDA Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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