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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 Reprocessing Problem (1091)
Patient Problem Unspecified Infection (1930)
Event Date 11/19/2019
Event Type  Injury  
Event Description
The service center was informed by the user facility that there is reportedly bacteria in the facility's water supply affecting the drinking water and the quality control group at the facility has determined that bacteria is passing through the automated endoscope reprocessor's (aer) internal water filter.As a result, the user facility has had to switch to a in-line bacteria filter for their drinking water supply.Patients at the facility have reported bacterial infection issues prompting the testing of their water supply.The facility noted that the bacteria in their water was a recurring issue at their facility.The patient details were not reported.
 
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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 Key9446696
MDR Text Key170213061
Report Number2951238-2019-01210
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2019,12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberOER-PRO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/19/2019
Event Location Hospital
Date Report to Manufacturer11/19/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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