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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Event Description
It was reported the endoscope reprocessor was missing springs on connector a and connector b.Additionally, there was a pressure error on the oer machine.This was found during reprocessing; there was no report of patient harm.
 
Manufacturer Narrative
The device was not returned to olympus, and it is not expected to be returned for evaluation of the reported issue.Upon an on-site assessment, it was determined that the damage to the connector in the basin was due to aged deterioration.A fse, field service engineer, replaced connector b scope connector in the basin.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 a year since the subject device was manufactured.Based on the results of the investigation, the customer-reported malfunction was most likely due to the internal springs that may have been missed when connectors in the reprocessing basin were broken.As a result of the breakage, it is likely that the user hit the connectors on something hard, or contributed stress to the connectors.The forward loosening direction was accumulated, which most likely made the connectors deteriorated over time.However, the root cause of the events could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: chapter 3.Inspection before use 5.6 inspecting the connectors check the following for each connector.The connector should be fixed firmly.The o-rings should be free of irregularities such as cracks, tears, or dents.If any irregularity is found, do not use the reprocessor and contact olympus.[warning] do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Olympus will continue to monitor the field performance of this de.
 
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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 Key18352230
MDR Text Key330966001
Report Number9610595-2023-19805
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170404047
UDI-Public04953170404047
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 Nurse
Type of Report Initial,Followup
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2023
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2022
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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