MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the lid of the endoscope reprocessor that was cleaned using 3m enzyme-detergent 70508e and disinfectant acecide appeared to be transparent.The issue was found during preparation for use for an unknown procedure.Manual cleaning, disinfection, sterilization (cds) process was followed by the site.It was also reported that sample was taken to determine what the transparent material was.There were no reports of patient harm associated with the event.This report is being submitted to capture the complaint on the scope that was reprocessed using the reprocessor with transparent material and cleaned using non-recommended chemicals.Patient identifier: (b)(6) captures complaint on the reprocessor (model: oer-aw, model description: endoscope reprocessor, serial number: (b)(4)).

Manufacturer Narrative

Regarding the use of non-recommended chemicals, it was confirmed that the facility makes the decision to use the detergents since the cleaning tests are done at the facility and the device will be used only after confirmation with the test results.The device will not be returned.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental will be submitted on completion of investigation or if any additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the definitive root cause of the reprocessing issue could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿always use the olympus-designated detergent.If a non-designated detergent is used, the endoscope may not be properly cleaned or the predetermined sterilization effect may not be achieved.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 16283225
• MDR Text Key: 308891675
• Report Number: 9610595-2023-01661
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OER-AW ENDOSCOPE REPROCESSOR (SERIAL NO. (B)(6)).