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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during a reprocessing, red foreign matter remained in the reprocessing basin of the subject device after cleaning.There was no report of patient injury associated with this event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The red foreign matter was returned to omsc for the analysis of component.The result of the component analysis, it was found that the red foreign matter was mainly composed of polysaccharides such as cellulose and was not fibrous.The red foreign matter may be mold, chemicals, residue of the reprocessed endoscope, etc., but it could not be identified.If additional information becomes available, this report will be supplemented.
 
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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 Key10371962
MDR Text Key201867201
Report Number8010047-2020-05323
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 health professional,user faci
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberOER-4
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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