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

Model Number OER-4

Device Problem Device Reprocessing Problem (1091)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the endoscope reprocessor was used to clean duodenovideoscopes in unknown multiple instances without attaching the cleaning adapter tube at the tip, and the improperly reprocessed devices were used to complete unspecified procedures on patients.The issue occurred during reprocessing.There were no reports of patient harm and the intended procedure was completed with a similar device.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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 six (6) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: for the scope reprocessed without the use of the connecting tube has been utilized for patients: it is presumed that the user did not thoroughly read the instruction manual and has implemented the reprocessing without the use of the connecting tube.And for the disinfectant solution concentration level each time has been checked after exceeded 20 times it is presumed that even though a person in charge at the facility has understood that checking each time the disinfectant solution concentration level is required when implementing reprocessing, it has been managed in accordance with the facility-specific operating rules, which was out of line with the description in the instruction manual.The suggested event can be detected and prevented in line with the instructions for use below.[oer-4 instruction manual operation manual].Chapter 3 inspection before use 3.9 inspecting the disinfectant solution¿s concentration level.[warning] check the concentration of the disinfectant solution with the test strip each time an endoscope is disinfected.If this check is not performed, the disinfection process may be ineffective.Replace the disinfectant solution before the disinfecting effect is lost.Chapter 4 basic endoscope reprocessing operations 4.8 connecting tube installation.To find out what connecting tubes can be used, refer to the provided ¿list of compatible endoscopes/connecting tubes ¿.[warning] attach all of the connecting tubes specified according to the type of the endoscope.If reprocessing is performed without attaching all of the required connecting tubes, reprocessing may be ineffective.Although the ¿list of compatible endoscopes/connecting tubes ¿ shows the applicable connecting tubes for each endoscope, it may not list the latest endoscope models.If your endoscope model is not listed, contact olympus for more information.[list of compatible endoscopes/connecting tubes ] it is confirmed that the maj-1500 and the maj-2358 are the connecting tubes applicable to tjf-q290v.Olympus will continue to monitor field performance for this device.

Event Description

The procedure was completed using the same set of equipment.

• 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: 18811480
• MDR Text Key: 337631199
• Report Number: 9610595-2024-04292
• 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,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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
• Treatment: EVIS LUCERA ELITE DUODENOVIDEOSCOPE