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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 03/19/2020
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
Olympus was informed from the facility that in unspecified timing the air/water/instrument channel connector of the reprocessing basin of the subject device was broken and a local service engineer repaired the subject device at the facility.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 subject device, because the subject device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Since the subject device was not returned, the exact cause was unknown.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 Key10187647
MDR Text Key198165896
Report Number8010047-2020-03598
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 Received06/24/2020
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 Received07/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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