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

Model Number GIF-HQ190

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Event Description

It was reported that the nurse manager requested an in-service to be provided to their new hire employees for the reprocessing of gastrointestinal videoscope.During in-service it was noted that the staff were not dosing the enzymatic detergent appropriately according to the manufacturer requirements (ratio of detergent with water for 500ml) when pre-cleaning the endoscope.Staff did not have access to the olympus air/water cleaning adapter for pre-cleaning.Staff did not have the channel opening cleaning brush to use when manually cleaning the endoscope.In-service training was completed, attendance documented, and copy of training forms provided to the facility nurse manager.There were no reports of patient harm or impact associated with this event.

Manufacturer Narrative

The endoscopy support specialist (ess) noted that the facility did not have adequate supplies to complete the reprocessing process.The ess was able to locate one air/water cleaning adapter that was kept in a drawer, still in packaging.The ess showed the staff how to use this adapter for pre-cleaning as well as the function of the button and why it needed to be used for every endoscopes during pre-cleaning.Discussed the need for one adapter to every endoscope owned.While the staff did not have any channel opening brushes to use at that moment, the ess discussed the steps required for this brushing and how to do it, also referencing their reprocessing wall chart the staff had access to.Since the facility has 190 endoscopes, the ess did let the staff know they can use potable sink water for their pre-cleaning so that they are not improperly mixing their enzymatic detergent.The ess also suggested the use of pre-packaged enzymatic cleaner which is used for the purpose of pre-cleaning endoscopes.The facility nurse manager was not onsite to provide all this information to, although the ess did provide all information to her in an email, including the need for additional air/water cleaning adapters as well as channel opening brushes.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint for incorrect reprocessing was confirmed.Based on the results of the investigation, the definitive root cause of the reprocessing issue could not be determined.It is possible that the user¿s understanding on device handling and reprocessing steps differed from recommendation by olympus.Olympus has already conducted training on correct device handling at the facility.The following is included in the instructions for use (ifu):preventive measure is described in ifu: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

Event Description

There were no reports of patient involvement.

• Brand Name: EVIS EXERA III 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: 19202478
• MDR Text Key: 341681634
• Report Number: 9610595-2024-08845
• Device Sequence Number: 1
• Product Code: FDS
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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: GIF-HQ190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2018
• 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