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

Model Number CF-HQ190L

Device Problem Increase in Pressure (1491)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.The device was serviced by a third party in response to this event.The customer provided the third party evaluation of the device.Third party evaluation of the suspect device reveals: the scope passed the leak test.Auxiliary water channel pressure is too high (reading not provided).Angulation system needs an adjustment.Insertion tube is in excellent condition.Scope is in excellent condition.Removed debris from auxiliary water channel at distal end.Functional test performed.Reset angulation to manufacturer specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr#(b)(4).

Event Description

It is reported during a screening colonoscopy using an evis exera iii colonovideoscope, debris was lodged in the auxiliary water channel at the distal portion of the scope causing the scope and the water irrigation pressure to be too high resulting in mucosal injury and minimal bleeding in the cecum.The patient required a second planned colonoscopy to re-evaluate/assess the injury.There were no identified issues during the second procedure.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device was reviewed and it was determined the device met all accordance with all design and safety specification when it was shipped.Nov 15, 2018 was the last time the scope was sent to olympus for maintenance/repair.It is reported the device was sent to the third-party agency for repair after occurrence of the reported event.Therefore, we presume that the device has been repaired by the third-party agency.Conclusion: the definitive root cause could not be identified.Discussion: we cannot specify the definitive cause of the reported events since the subject device was sent to the third-party agency for evaluation and repair instead of olympus.Based on the information reported and the investigation findings, we presume the event was not due to structure of the device or assembly of the device by olympus.The user reported that ¿clogged debris in auxiliary water channel opening caused the event¿.However, the debris could not confirmed by olympus.Although there was no direct information to indicate misuse, the instructions for use (ifu) provides the following information to ensure no blockage (resulting in increased pressure) is present prior to a procedure: chapter 3 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.Chapter 4 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.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional findings from the legal manufacturer's final investigation.Based on the additional investigation findings, debris lodged in the auxiliary water channel at the distal portion of the scope was confirmed.Although foreign material was confirmed, the specific material could not be identified.It was not confirmed whether the reprocessing method deviated from the instructions for use (ifu).Correction to g3 of the initial medwatch.The aware date should be 21-jun-2021.Also, correction to h4 of the initial medwatch.The device manufacturer date should be 19-mar-2014.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12153427
• MDR Text Key: 267558108
• Report Number: 8010047-2021-08747
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 84 KG