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 Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that the gastrointestinal videoscope was incorrectly reprocessed.The customer did not have a suction machine and aspiration was not performed during manual cleaning.In addition, the auxiliary water tube was not used to flush the auxiliary channel.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This report is related to linked patient identifier (b)(6).The evaluation of the event is ongoing.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 device evaluation and 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.No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) had been dispatched on-site to assess the reprocessing practices at the user facility.Based on the observation summary report, there were some reprocessing deviations observed during the visit, and they were as follows: the customer did not have a suction machine and was not performing aspiration during manual cleaning.Additionally, the customer was not using the maj-855 to flush the auxiliary channel.Leak testing, manual cleaning, and storage were reviewed, and the process for aspirating detergent solution and using the maj-855 was explained.The staff understood the process.The customer was notified to purchase a suction machine, mh-856 suction cleaning adapters, maj-855 auxiliary water tubes, mh-946 injection tubes, and mh-944 channel plugs.A scope reprocessing and infection control in-service was also performed, covering leak testing, manual cleaning, and storage, as well as infection control information from the user and reprocessing manuals.All products were listed on the on-track form, and attendees were listed on the attendance sheet.The customer was advised to contact the manufacturer of their non-olympus automated endoscope reprocessor (aer) for proper use.The ess provided a reprocessing in-service or reprocessing training to the user facility staff.The ess provided the user facility staff reprocessing training materials for their reference.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that there was difference of recognition on device handling and reprocessing steps between the user and recommendation by olympus.The olympus technician has already conducted training for the user on proper handling.The event can be prevented by following the instructions for use: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope states preventive measures.Olympus will continue to monitor field performance for this device. .

• 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: 19093786
• MDR Text Key: 340236273
• Report Number: 9610595-2024-07699
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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