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

Model Number OER-4

Device Problem Flushing Problem (1252)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The customer stated that the concentration was not checked every time, instead it was performed after 2 weeks.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the endoscope reprocessor had an e99 error and a white material attached to the scopes that were washed.The issue was found during reprocessing.There were no reports of patient harm.Related patient identifiers: (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the customer.

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, the definitive root cause of the foreign material and concentration check issue could not be determined.It is possible that failure of secured precleaning before the manual cleaning may have left some kind of uncleaned material remained and that the user mishandled the management method of the disinfectant solution.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 4 basic endoscope reprocessing operations.4.3 endoscope precleaning and manual cleaning.·perform at least the processes from precleaning to manual cleaning that involves cleaning the outer surfaces of the endoscope, brushing the area around the forceps and the suction channel, and cleaning the valves.·always preclean each endoscope immediately after the examination.If precleaning is not executed promptly, debris will solidify and may prevent effective reprocessing.·failure to preclean will leave excessive amounts of debris adhering to the endoscope and may compromise the effectiveness of the reprocessing.It may also result in debris accumulating in the endoscope, preventing the endoscope from working correctly.¿, as well as "¿chapter 3 inspection before use 3.9 inspecting the disinfectant solution¿s concentration level on reprocessing an endoscope, always use an acecide checker or a portable concentration checker to check that the disinfectant solution is at an effective concentration.Please be sure to replace the disinfectant solution before the disinfectant effect disappears.¿ olympus will continue to monitor field performance for this device.

• 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 Key: 16118207
• MDR Text Key: 308784454
• Report Number: 9610595-2023-00361
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2023

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 Number: OER-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/11/2023; 02/13/2023
• Supplement Dates FDA Received: 01/18/2023; 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1