MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III COLONOVIDEOSCOPE

Model Number CF-HQ190L

Device Problems Partial Blockage (1065); Leak/Splash (1354)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the reported event of no air water flow issue from the flow system.The evaluation uncovered that the device nozzle was clogged with foreign material.Additionally, there was air water leakage from the channel and a dent on the device.The faulty parts were replaced.The device was inspected and passed olympus functional standards.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

A user facility returned the olympus evis exera iii colonovideoscope due to no air water flow issue from the flow system during a procedure.Upon inspection and testing of the returned device, it was observed that foreign material was exiting from the air and water nozzle.This report is being submitted for the event found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

E2, e3: three attempts were performed to obtain occupation for the reporter but were not successful.If additional information is obtained at a later date, a supplemental report will be submitted.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.Based on the results of the investigation, a definitive root cause could not be established.The investigative results, it was determined that the air/water nozzle was clogged with "white foreign object".It was therefore presumed that the cause of the suggested phenomenon was foreign material such as gauze, a piece of a peripheral device, body fluid, and an adherent that came from used chemical agents.The instructions for use states to remove foreign objects on the distal end by flushing the distal end and feeding water to the air/water channel.The user is able to detect the suggested event by handling the device in accordance with the following instructions for use (ifu): "inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities." the user may be able to reduce/prevent occurrence of the suggested event by handling the device in accordance with the following ifu: "clean the external surface: thoroughly brush or wipe all external surfaces of the endoscope, using clean lint-free cloths, brushes, or sponges.Pay particular attention to the air/water nozzle opening and the objective lens on the distal end of the insertion section, and confirm that all debris is removed from all surfaces of the distal end." the ifu further states: "flush the air/water channel with water and air.Caution: to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the aw (air/water) channel cleaning adapter (mh-948) after each patient procedure." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12669699
• MDR Text Key: 282039476
• Report Number: 8010047-2021-13457
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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