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

Model Number CF-H180AL

Device Problems Device Reprocessing Problem (1091); Increase in Pressure (1491)

Patient Problem Hematoma (1884)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the device: the videoscope cf-h180al, serial number (b)(4) was returned to olympus.Olympus was able to replicate the user¿s report of "too much pressure from the water channel." olympus performed a functional inspection in the as received condition to verify the auxiliary water flow.First, olympus attached an auxiliary water tube (mh-855) in conjunction with a 50ml syringe to the auxiliary inlet of the complaint device.While pressing down the syringe, olympus verified water was emitting forward from the distal end as the flow of water was consistent.In addition, the complaint device was also tested with a test ofp-2 flushing pump as the flow rate was adjusted to high.The footswitch on the test unit was pressed to operate the ofp-2 and discovered the diameter of water flow was very thin.Mq also noted the sound of the water contacting a solid object was very sharp.The flow rate setting was reduced to medium, and the results were the same as the water flow was thin.Additionally, a visual inspection was performed as an olympus fiberscope was inserted into the opening at the distal end to verify the condition of the auxiliary water channel.Upon entry, olympus discovered foreign material channel.This report will be updated upon completion of the investigation or receipt of additional pertinent information.

Event Description

The customer reports during a diagnostic colonoscopy using an evis exera ii colonovideoscope, the physician felt the water pressure coming out of the scope was too great because it was creating hematoma like bubbles on the colon wall.The customer later clarified; the patient did not have any injury.No treatment/intervention was needed.The patient's current condition is listed as good/stable.The scope was returned to olympus for inspection and evaluation.A visual inspection was performed using a fiberscope inserted into the opening at the distal end to verify the condition of the auxiliary water channel.Upon entry foreign material was discovered in the channel indicating insufficient reprocessing.

Event Description

The customer reported that the patient had no pertinent health history and was undergoing a colonoscopy for indication of blood in the stools and chronic diarrhea.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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, it is likely the phenomenon occurred due to the water pressure was high because the tube was narrowed caused by the auxiliary water channel clogged with foreign material.It is possible the high pressure caused hematoma like bubbles on the colon wall.However, the root cause of the failure could not be identified.Additionally, olympus could not identify the foreign matter and the root cause could not be specified.The event can be prevented by following the instructions for use which state: "inspection of the auxiliary water feeding function".Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 15623884
• MDR Text Key: 307179325
• Report Number: 9610595-2022-03024
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170202339
• UDI-Public: 04953170202339
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2008
• 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
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 97 KG