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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 Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2023
Event Type  malfunction  
Event Description
The customer reported to olympus, the olympus endoscope reprocessor received an e14 "disinfectant is not collected in the tank" error code during operation.After cleaning the mesh, an e12 "insufficient amount of disinfectant in the disinfectant tank" error code was still received.The issue was found during reprocessing.Inspection and testing of the returned device found that a water filter that appeared to be expired was installed; the start date was december 22, 2022.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
 
Manufacturer Narrative
The device was returned to olympus for evaluation.The store representative replaced the switching valve and checked the operation, but e12 continued.The error was resolved eventually.The scopes used in this case were pcf-h290di w/br, gif-n260, gif-pq260, gif-xp260, gif-xp260ns, gif-xp260ns, gif-1200n w/br the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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 replacement of the water filter was not being implemented could not definitively be determined, however, the issue was likely the result of it the user not reading the instruction manual carefully and or made a mistake in the user management of the water filter replacement.The event can be detected/prevented by following the instructions for use which states: instructions, operation manual for oer-6, chapter 7 ¿routine maintenance¿ section 7.3 replacing the water filter (maj-2317)¿ replace the water filter periodically, at least once per two months 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.Replace the water filter according to the procedure described below.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 Key17830354
MDR Text Key324446856
Report Number9610595-2023-14179
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/01/2023
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-6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/10/2023
Initial Date FDA Received09/27/2023
Supplement Dates Manufacturer Received11/01/2023
Supplement Dates FDA Received11/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
GIF-1200N W/BR.; GIF-N260.; GIF-PQ260.; GIF-XP260.; GIF-XP260NS.; GIF-XP260NS.; PCF-H290DI W/BR.
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