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

Model Number OER-AW

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following: reprocessor indicates error e83 (irregularity inside the reprocessor); evening alarm activation (periodic indicator of lack of maintenance); manipulation of electrical elements, electronic electronics and cables internal connection by third party unauthorized persons by olympus; reprocessor indicates oxidation and calcifications of liquids inside the team; faulty water pumps maintenance and samples possible wear and tear due to loss of fluids (through joints /packaging), present handled by unauthorized persons by olympus; right top of the reprocessor presents oxidation, calcification of liquids and cuts in the electrical insulator, could present electrical hazard; reprocessor presents accumulation of dust inside the equipment; level sensors wear and tear, sensor protectors broken and worn; reprocessor features bumps and/or possible handling by unauthorized persons by olympus; location on the outside right; air filter changes and water not updated, legends of change present dates of the 2021; and it is not possible to obtain the list of errors through of the olympus software.Loss; disposal of codes and history; reprocessor oxidation and calcifications of liquids inside the reprocessor; water pumps with lack of maintenance and samples possible wear and tear due to loss of fluids (through joints /packaging), presently handled by people unauthorized by olympus; right top of the reprocessor oxidation, calcification of liquids and cuts in the electrical insulator, could present electrical hazard; reprocessor oxidation and calcifications of liquids inside the equipment, can present danger electric.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the endoscope reprocessor, displays error 83 (irregularity in the electrical circuitry inside the device), and requested a technical visit to fix the issue.The issue occurred during an unknown event.The procedure was diagnostic.There are no reports of patient or user harm associated with this event.The device was returned to olympus and the evaluation found that the water filter replacement deadline has expired.This report is being submitted to capture the reportable malfunction found during evaluation.

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 customer did not follow the instructions for use (ifu) regarding water filter replacement.The cause of the deviation from the ifu was not established.The occurrence of the reported problem can be prevented by adhering to the ifu which states the following: ¿replace the water filter at least once a month to prevent contamination of the rinse water.The water filter should also be replaced whenever an error code indicating water supply insufficiency [e01] is displayed.The water filter should be replaced by following the flow shown below.¿ 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: 18384063
• MDR Text Key: 331222370
• Report Number: 9610595-2023-20231
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2013
• 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