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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

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AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-ELITE
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
It was reported that while performing an in-service post it was found that the internal water and air filters had not been changed since the date of install.There were no reports of patient harm.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the internal water and air filters had not been changed was the user did not read instructions for use carefully.¿chapter 8 replacement of consumable items 8.4 replacing the water filter (maj-824 or maj-2318) to prevent contamination of the rinse water, the water filter should be replaced every month when the prefilter is not used or every six months when the prefilter is used.Warning ·replace the water filter at least every month when the prefilter is not used or every six months when the prefilter is used.If the water filter is not replaced regularly, the performance of the water filter drops, and insufficient elimination of microorganisms in the water may cause contamination of the reprocessor piping.As a result, the reprocessing of endoscopes will be insufficient.¿ olympus will continue to monitor field performance for this device.
 
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Brand Name
ENDOSCOPE REPROCESSOR
Type of Device
ENDOSCOPE REPROCESSOR
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18679908
MDR Text Key335950669
Report Number9610595-2024-02852
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/21/2024
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-ELITE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/25/2024
Initial Date FDA Received02/09/2024
Supplement Dates Manufacturer Received03/13/2024
Supplement Dates FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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