• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-PRO
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned.Tac assisted the customer in resolving the issue and the customer was able to use the oer-pro without the detergent light being illuminated.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
The customer contacted olympus technical assistance center (tac) stating the detergent light was illuminated on the main panel of the oer-pro after replacing the detergent container and successfully priming the detergent lines.The customer confirmed they did not perform a wash cycle.Tac had the customer execute a wash cycle and the detergent light went out.There was no patient involvement.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the detergent indicator issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 2 nomenclature and functions: 2.5 control panels.Main control panel.Detergent replacement indicator.The lamp blinks when detergent tank needs to be replaced.The error code [e95] is also displayed.Chapter 4 reprocessing operations: when the error code [e95] is displayed during the reprocessing process if detergent has run out and the error code [e95] is displayed, the equipment will stops the process.In this case, you need to start the reprocessing process from the beginning after replenishing the detergent.Follow the procedure described in section 3.5, ¿inspecting and replacing the detergent tank¿ on page 44 for replacing the detergent tank, then press start button to restart the reprocessing process.¿ olympus will continue to monitor field performance for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Contact
masaharu hirose
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8-520
JA   965-8520
426422891
MDR Report Key15487278
MDR Text Key306353700
Report Number9610595-2022-02251
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/09/2023
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
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/31/2022
Initial Date FDA Received09/26/2022
Supplement Dates Manufacturer Received12/15/2022
Supplement Dates FDA Received01/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-