MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number CF-HQ290L

Device Problem Partial Blockage (1065)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation confirmed the reported event due to blockage protruding from the air and water nozzle of the device.The blockage appears to be a black rubber like material which was assumed to be due to usage of the device.The faulty parts would be replaced.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

It was reported to olympus that, the evis lucera elite colonovideoscope had a low air flow.During inspection and maintenance of the returned device, it was observed that foreign debris was found protruding from the air and water nozzle.There was no harm, infection or user injury reported due to the event.

Manufacturer Narrative

Correction to g2 to add the foreign country united kingdom.Correction to h4, the manufacturing date was (b)(6) 2015.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 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the injection tube or a silicone rubber product was broken and debris entered the air/water channel, clogging the nozzle.This foreign material was likely present because the user facility was not trained sufficiently on device handling and reprocessing steps in accordance with the instructions for use.The following is included in the instructions for use (ifu) and may have prevented the foreign material clogging the air/water channel: ¿operation manual_ preparation and inspection inspection of the endoscope_ inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities operation manual_ inspection of the endoscopic system - inspection of the air-feeding function - inspection of the objective lens cleaning function¿ the following is included in the instructions for use (ifu) and may have prevented improper reprocessing: ¿reprocessing manual_ precleaning the endoscope and accessories 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 channel cleaning adapter (mh-948) after each patient procedure.-manually cleaning the endoscope and accessories_ clean the external surfaces of the insertion section *immerse the endoscope in the detergent solution.*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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 12516749
• MDR Text Key: 272882752
• Report Number: 8010047-2021-12155
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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