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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-4
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
To date, the customer have not returned the device for evaluation.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Pre-cleaning was completed immediately after the procedure and involved aspiration of water through the instrument/suction channel with a suction pump.The air/water channel was flushed with the air/water channel cleaning adapter.Manual cleaning was done after the procedure.The scope passed a leak test.Super flash detergent manufactured by adachi was used for manual cleaning.The instrument/suction channel, suction channel, and instrument channel port were brushed during manual cleaning.Manual disinfection was not done.An olympus oer-4 automatic endoscope reprocessor (aer) was used with endoquick as the detergent and acecide as the disinfectant.There were no defects with the aer.All channels were connected with tubes when setting up the aer, the concentration and expiration of the disinfectant was controlled, the disinfectant met the minimum effective concentration, the water quality was controlled.The water filter was not replaced in accordance to the instruction for use (ifu).The scope was dried using a clean towel and then stored in a cabinet without drying function at room temperature and normal air concentration.
 
Event Description
The customer reported to olympus that it was possible that an unknown scope model was reprocessed after it was discovered that the water filter of the olympus endoscope reprocessor (oer-4) was replaced every two months at the facility's discretion and the replacement deadline had passed.It was unknown if the scope was used clinically after reprocessing.There were no reports of patient harm.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause of the reported oer-4 water filter not being replaced in accordance with the ifu could not be determined, however, the issue was likely due to the facility/user not reading or following the instruction manual carefully, resulting in mismanagement of the water filter replacement.The event can be detected/prevented by following the instructions for use which states: chapter 7 ¿routine maintenance¿ section 7.2 ¿replacing the water filter (maj-2318)¿ replace the water filter periodically, at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever the error code [e01] indicating water supply insufficiency is displayed.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 Key18111557
MDR Text Key329228628
Report Number9610595-2023-16919
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/05/2023
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-4
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/29/2023
Initial Date FDA Received11/10/2023
Supplement Dates Manufacturer Received11/13/2023
Supplement Dates FDA Received12/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2018
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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