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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-PRO
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2023
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation.Olympus technical assistance center advised the customer to do an air purge of the internal filter to resolve the issue.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, it is likely that the following led to the malfunction: the air purge after replacing a water filter was insufficient or omitted; however, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): "chapter 4 installation of equipment 4.12 discharging air from the water filter housing caution: after attaching the water filter, be sure to discharge air from the water filter housing completely.If air is left in the water filter housing, the process time may be extended.Air should be removed whenever process time is extended or other irregularity are noticed." olympus will continue to monitor the field performance of this device.
 
Event Description
The customer reported to olympus that the endoscope reprocessor was experiencing an abnormally long cycle time.The issue was found during reprocessing.There were no reports of patient harm.
 
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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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18114760
MDR Text Key328021114
Report Number9610595-2023-16954
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170258589
UDI-Public04953170258589
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/10/2023
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received11/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2019
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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