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

Model Number GIF-H190

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

The endoscopy support specialist (ess) provided a reprocessing in-service to the user facility staff, and the observations are as follows: the customer did not have good control of the scope when placing it into the washer.They placed the scope knobs down in the medivator also.It was also not observed if the customer inspected and made sure the accessories were in good working condition or if they did the appropriate rinses or terminal cycles were performed.The ess provided the user facility staff reprocessing training materials for their reference.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, that during a repair reduction observation, an ess (endoscope support specialist) observed a 3rd party cleaning brush used only to brush straight inside the suction cylinder until it came out of the suction connector and then brushed down the biopsy port until it came out of the distal end.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6 and h10.Corrected data field: d8, g2, h6 (medical device problem code).A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was evaluated by a field service engineer and the customer's complaint was confirmed.In addition, a repair reduction observation was made, during the observation, it is observed that the client used a third-party cleaning brush and only brushed it directly inside the suction cylinder until it came out of the suction connector and brushed the biopsy port until it came out through the distal end.Based on the results of the investigation, a definitive root cause could not be determined.However, it is like that the event reported as "there was a deviation in reprocessing steps " was caused by a there was a difference in recognition on device handling or reprocessing steps between olympus recommendation and the user facility.Olympus expert staff has already conducted training on proper reprocessing for the user facility.The event can be detected/prevented by following the instructions for use which state: preventive measure is described in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.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: 18977251
• MDR Text Key: 338602267
• Report Number: 9610595-2024-06336
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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-H190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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