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

Model Number OER-S

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.A review of the device history record found no deviations or non-conformities in the manufacturing and shipping of the device.It has been over 4 months since the subject device was manufactured.Based on the investigation result, there was information the user implemented the subject event intentionally because of dissatisfaction of the consumption cost of acecide.Therefore, the subject event is considered to have occurred due to the user¿s mishandling.Additionally, the user failed to thoroughly read the provided instructions for use.Therefore, the subject event is considered to have occurred due to the user¿s mismanagement of the concentration level of the disinfectant solution.This issue is addressed in the instructions for use (ifu): chapter 3 ¿inspection before use¿.Section 3.12 ¿inspecting the disinfectant solution¿s concentration level¿.Before reprocessing the endoscope, be sure to check that the disinfectant solution has an effective concentration by using test strip.Also, be sure to replace the disinfectant solution before it loses its effectiveness.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.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus the endoscope reprocessor was used with expired acecide, and the concentration had not been checked.The acecide was used for 51 days before changing.This was done intentionally under the direction of the hospital director.The facility had acecide and concentration checkers in stock but neglected to use them appropriately.Currently, there are no reports of health damage from this event.This report is related to linked (b)(6).

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18084764
• MDR Text Key: 327538662
• Report Number: 9610595-2023-16614
• 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: Physician
• Type of Report: Initial
• Report Date: 11/07/2023

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-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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