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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
The reported problem was resolved through an onsite service visit by an olympus field service engineer (fse).The fse inspected all disinfectant hoses for evidence of degradation; tank hose 1, tank hose 2 and the disinfectant hose were replaced due to degradation.
 
Event Description
A user facility reported to olympus that a black substance was observed in the mesh filters inside the basin.There was no patient injury or harm, associated with the problem, reported to olympus.
 
Manufacturer Narrative
Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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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 Key10373474
MDR Text Key201893773
Report Number8010047-2020-05337
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 health professional,user faci
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 07/14/2020
Initial Date FDA Received08/06/2020
Supplement Dates Manufacturer Received08/25/2020
Supplement Dates FDA Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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