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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-2 100V; ENDOSCOPE REPROCESSOR
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OLYMPUS MEDICAL SYSTEMS CORP. OER-2 100V; ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-2
Device Problem Failure to Disinfect (1175)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.Omsc obtained the followings information from the user facility.-the user facility used endoscopes that had been reprocessed with the subject device for 12 patients.The user facility is undergoing blood tests on the patients.Blood tests will be performed 5 times.-the facility will not perform a bacteriological examination of endoscopes that have been reprocessed by the subject device.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
The disinfectant used in the subject device had expired.There is no report of patients injury associated with this event at this time.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.This event occurred because the user has changed the display settings by mistake.If additional information becomes available, this report will be supplemented.
 
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Brand Name
OER-2 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 Key10126893
MDR Text Key194286265
Report Number8010047-2020-03178
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 Received06/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-2
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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