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

Model Number OER-4

Device Problem Contamination (1120)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was sent to an olympus service center for evaluation.Inspection and testing is in progress.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 reported that when staff collected water from the cleaning tank of the endoscope reprocessor, a mold-like foreign object came out of the water supply port.The reprocessor had not been used recently.The water supply pipe was disinfected and foreign objects were recovered.An olympus technician visited the site and found that water supply pipeline disinfection was not performed during the water filter change.It was determined that an endoscope that was incorrectly reprocessed may have been used on a patient.There was no harm or user injury reported due to the event.This report is for the oer-4 endoscope reprocessor.The endoscope is being reported on the medwatch with patient identifier: (b)(6).

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 reprocessor has not been used for scope reprocessing since the foreign material was found.However, the definitive root cause of the reprocessing error could not be determined.It is possible that the user did not read the instruction manual carefully, or did not have enough knowledge about replacing the water filter and disinfecting the water supply piping.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 7 routine maintenance: 7.3 disinfecting the water supply piping: disinfection of water supply piping is required in the following cases: ¿ before using this equipment for the first time (after installation of the water filter set).¿ immediately after replacement of the water filter.¿ whenever bacteria are identified in the water supply piping.¿ before using the equipment when it has not been used for more than 14 days warning.·before disinfecting the water supply piping, check the potency of the disinfectant solution with the test strip, and replace the disinfectant solution if the disinfectant effect is below the required level.If this check is not performed, prevent effective reprocessing.·disinfection of the water supply piping is required each time the water filter is replaced (i.E., at least once a month).In addition, since there is a risk that various bacteria may be mixed in the water supply piping depending on the usage environment, microbiological sampling of the rinse water may indicate disinfection is required.¿ 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15715851
• MDR Text Key: 307598863
• Report Number: 9610595-2022-03576
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2013
• 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