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 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the gastrointestinal videoscope had insufficient or incorrectly reprocessed equipment used for the next procedure.The field service engineer noticed that some of the leak testing steps were missed.Including not inspecting the device prior to attaching to the endoscope and not angulating the control knobs while the endoscope was under water.Also, during manual cleaning, the customer did not brush the scope under the detergent.The customer held the control body outside the detergent while brushing the scope.The issue occurred during an unspecified procedure.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information provided and the legal manufacturer's final investigation.New information was added to the following fields: d8, and h6.Note that d9 yes was selected in error and h3 no was selected in error, there are no updates for these fields.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.An olympus endoscopy support specialist went on-site and observed the reprocessing steps being performed by the customer.The following reported issues were confirmed: during the leak test, the customer did not inspect the mb-155 prior to connecting to the endoscope, and the control knobs were not angulated during the leak test.During manual cleaning, the customer was not brushing the scope while submerged in the detergent.Additionally, the following issues were observed: during the automatic endoscope reprocessor (aer) section, the customer did not protect the distal tip of the scope when loading the scope in the oer-pro causing the distal tip to strike across the front panel of the oer-pro.When transporting, the customer did not have the transport container in an upright secure position and the scope was transported with the control knobs face down in the transport container.The customer was informed how to properly perform the steps according to the olympus instructions for use (ifu).Three attempts were performed to obtain additional information regarding whether improperly reprocessed scopes were used on patients, but no response was received from the customer.Based on the results of the investigation, it is likely that incorrect reprocessing was being performed due to a difference in recognition on device handling or reprocessing steps between olympus recommendations and the user facility.The issue can be detected/prevented by following the instructions provided 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: 18947736
• MDR Text Key: 338308532
• Report Number: 9610595-2024-05989
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2012
• 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