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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR
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OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-4
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
During reprocess with the subject device, the user found the lid of the subject device was cracked.Other detailed information was not provided.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Omsc reviewed the manufacturing history of the device and confirmed no irregularity.According to additional information, the customer pressed the lid down too hard when closing the lid and the lid hit the endoscope sitting in the basin.The exact cause has been unknown; however, this handling might have caused the reported event.The instruction manual of the subject device states the corresponding method in case of an abnormality.
 
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Brand Name
OER-4 100V
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 Key10287070
MDR Text Key211544928
Report Number8010047-2020-04487
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-4
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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