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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 Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
An olympus field service engineer (fse) was dispatched to replace the damaged lid.The device passed all the service inspections.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 that a lid was cracked on an oer-pro endoscope reprocessor.No patient involvement or injury was 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 shipped according to specifications.The instructions for use (ifu) includes the following statements: before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.·the lid is not cracked, broken, or otherwise damaged the user followed the ifu and reported the cracked lid.
 
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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 Key11342210
MDR Text Key232576262
Report Number8010047-2021-02828
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 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
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 Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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