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

Model Number OER-5

Device Problem Device Reprocessing Problem (1091)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported to olympus, an endoscope reprocessor was used in conjunction with a damaged connecting tube, leading to inadequately cleaned scopes.The scopes were used in approximately (b)(4) gastrointestinal procedures.There were no reports of patient harm associated with the event.This medical device report (mdr) is being submitted to capture the endoscope reprocessor.

Manufacturer Narrative

Full e1: establishment name: (b)(6) hospital.The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.This medical device report (mdr) is related to mfr report number: 9610595 - 2024 - 01728.

Event Description

The end-user facility has provided additional information stating that a total of 10 patients were impacted by the inadequately reprocessed endoscopes; not the originally reported 20.None of these 10 patients experienced any adverse health effects from use of the inadequately cleaned endoscopes.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided by the end-user regarding the reportable event description.Refer to the b5 field.This mdr is related to the following mfr report #s: 9610595-2024-01728 9610595-2024-01991 9610595-2024-01989 9610595-2024-01990 9610595-2024-02038 9610595-2024-02037 9610595-2024-02061 9610595-2024-02072 9610595-2024-02103 9610595-2024-02071 9610595-2024-02068 9610595-2024-02065 9610595-2024-02097 9610595-2024-02063.

Manufacturer Narrative

This report is being supplemented to provide additional information including further information provided by customer and the legal manufacturer's final investigation.According to the customer, regarding the connecting tube, although alcohol is not used for cleaning, the tubes are wiped dry and stored together with other tubes in a container lined with a towel, everything is straight and without any bends.The oer re-processor is used according to the instruction manual.There is no stress applied when the tube is installed.Removal is performed without any stress being applied to the tube, but when replacing the scope between inspections, with the tube still attached to the main body, the scope is raised so that it does not get in the way when taking the scope in and out.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 users failed to notice the damaged connecting tube during pre-use check.It is possible that stress may have been applied (through attaching scopes or while assembling), the connecting tube may have encountered something sharp or, the connecting tube deteriorated over time.However, the specific cause of the damage could not be determined.The issue can be detected/prevented by following the instructions provided in: operation manual for maj-1500, chapter 7 preparation and inspection.Warning - over time, the connecting tube will deteriorate because it is subject to wear with each use.If any of the following are found with the connecting tube, do not use it and replace it with a new one.Connecting a defective tube could prevent the effectiveness of the cleaning and high-level disinfection process.1.Visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.Operation manual for oer-5, chapter 3 inspection before use, 3.4 inspecting the connecting tubes and leak test air tube.Before using the equipment, always check that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.-all tubes should be free of cracks, breaks, fissures, scratches, or stains.-there should be no cracks in the lock levers of connecting tube connectors.-there should be no bends or breaks in the pin of connecting tube connector.-the tube should not be easy to disconnect once connected.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: 18608291
• MDR Text Key: 335106419
• Report Number: 9610595-2024-01990
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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
• Treatment: GIF-1200N GASTROINTESTINAL (GI) VIDEOSCOPE; GIF-EZ1500 GASTROINTESTINAL VIDEOSCOPE; GIF-H290 EVIS LUCERA ELITE GI VIDEOSCOPE; GIF-HQ290 EVIS LUCERA ELITE GI VIDEOSCOPE; MAJ-1500 CONNECTING TUBE