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

Model Number PCF-H190DL

Device Problems Contamination (1120); Increase in Pressure (1491)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for evaluation.Preliminary findings were reported.The investigation is ongoing.Physical evaluation of the device: 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 suppressed to operate the ofp and discovered the of water flow was spraying out instead of a consistent stream of water.Olympus 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 spraying.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 around the channel wall.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a screening colonoscopy using an evis exera iii colonovideoscope, the irrigation water pressure seemed to be amplified when using this scope.The patient experienced a superficial mucosal bleb with mild oozing of blood.The patient is fine and did not require any treatment/intervention.Endotherapy used in the procedure includes one cold snare for a 6mm sigmoid polyp (cannot provide the lot number).Per procedure note, no mention of difficulty passing the scope.

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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 4 years since the subject device was manufactured.Based on the results of the investigation, an orifice shape was formed inside the auxiliary water channel due to the foreign material that formed around the inner wall of auxiliary water channel.It is likely that colonic mucosal trauma occurred because of an increase in flow velocity due to a decrease in the cross-sectional area of the inner surface of the channel.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿preparation and inspection: inspection of the auxiliary water feeding function: attach a syringe containing sterile water or the water tube from a water pump to the luer port of the auxiliary water tube.Feed water and confirm that water is emitted from the auxiliary water channel at the distal end of the insertion section.¿.¿operating instructions: press the flow rate control to minimize the flow rate.For safety reasons, start the water flow at the minimum level and increase it progressively until the appropriate level for the patient's condition has been identified.¿.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 15607570
• MDR Text Key: 306889510
• Report Number: 9610595-2022-02955
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG