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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. OLYMPUS ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-6
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2024
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the olympus endoscope reprocessor had the first e99 outbreak and discovered that there was a mistake in the acecide check method.Even if the checker paper shows white (no concentration) 7 seconds after liquid removal, if it turns black over time, it has been incorrectly determined that there is no problem with the concentration.The issue occurred during reprocessing.There were no reports of patient harm or infections.
 
Event Description
The costumer reported that the event was completed with the same equipment.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and 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.It has been over one (1) year since the subject device was manufactured.The device was to olympus for inspection, and the customer's complaint was not confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the "incorrectly judge of judgement paper" malfunction would likely be related to the facility staff that used the aseside checker incorrectly, judging the concentration to be valid even when the reaction zone of the aseside checker turned black over a long period of time.The event can be prevented by following the instructions for use which state: follow the procedure described in the ¿instruction manual¿ of "how to use the acceside checker " to determine the concentration.Note 3: the reaction progresses over time and coloration proceeds.Please judge within the specified time.Olympus will continue to monitor field performance for this device.
 
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Brand Name
OLYMPUS 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 Key18699755
MDR Text Key336509174
Report Number9610595-2024-03096
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2024
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-6
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2024
Supplement Dates Manufacturer Received03/29/2024
Supplement Dates FDA Received04/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2023
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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