MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number PCF-H190DL

Device Problem Device Handling Problem (3265)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

The air/water (a/w) channel cleaning adapters were ordered by the facility on urgent basis.In the meanwhile the olympus endoscopy support specialist (ess) advised the operating room staff to use the a/w channel cleaning adapters form the gastrointestinal department.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

An olympus endoscopy support specialist (ess) performed a repair reduction in-service for the operating room staff by observing procedures and reprocessing for repair trends and ways to avoid and prevent common repairs.During pre-cleaning, ess observed that the air/water (a/w) channel cleaning adapter was used.The facility did not have the a/w channel cleaning adapter, nor was a disposable a/w channel cleaning adapter being used.Ess trained the staff for pre-cleaning steps per the instructions for use (ifu) including the importance of using an a/w channel cleaning adapter.There is no reported harm to any patient.

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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the user¿s understanding differing from the olympus recommendation in device handling and reprocessing steps.The instructions for use (ifu) (reprocessing manual) warns against insufficient reprocessing as follows: "precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them." the ifu (reprocessing manual) states the method of flushing the air/water channel with water and air and the method of flushing the auxiliary water channel at ¿5.3 precleaning the endoscope and accessories¿.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 15685279
• MDR Text Key: 306800850
• Report Number: 9610595-2022-03405
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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