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 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer¿s allegation was confirmed and was determined to be caused by water invasion in the video connector.The device evaluation found a blockage in the outlet pipe.The debris found was similar in appearance to a bristle of a brush.In addition, the device evaluation also found a gap in the adhesive of the bending rubber cover and loose/collapsed skeletons in the bending section.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the evis lucera elite colonovideoscope was displaying intermittent ¿fuzzy/color¿ lines during an unknown clinical procedure.Inspection of the returned device found debris protruding from the air/water nozzle.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This supplemental report is submitted to provide applicable corrections.Corrected fields: b5 (event occurred during reprocessing and not during a procedure) and e1 (removed reporter¿s name and corrected establishment name, address and telephone number), e2, e3 and g2 (removed health professional).

Event Description

The event occurred during reprocessing.The user facility considers reprocessing a clinical procedure.

Manufacturer Narrative

Correction to g2 to add the foreign country united kingdom.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 1 year since the subject device was manufactured.Based on the results of the investigation, the white brush bristle like materials in the air/water nozzle were likely caused from the brush when broken while brushing the channel or valve in reprocessing after previous procedure.This foreign material was likely present because the user facility was not trained sufficiently on device handling and reprocessing steps in accordance with instructions for use.The following is included in the instructions for use (ifu) and may have prevented foreign material clogging the air/water channel: "operation manual_ preparation and 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"."reprocessing manual_ function and inspection of the accessories for reprocessing_ channel cleaning brush (bw-20t) inspection: check the bristles for damage.If the bristles are crushed, gently straighten them with your gloved fingertips.·channel-opening cleaning brush (mh-507)_inspection: check the bristles for any damage.If the bristles are crushed, gently straighten them with your gloved fingertips.·single use combination cleaning brush (bw-412t) -check the channel cleaning brush and channel-opening cleaning brush parts for loose or missing bristles.-caution: do not reprocess the single use combination cleaning brush prior to use.The brush may be damaged.·manually cleaning the endoscope and accessories_ brush the channels the channel cleaning brush (bw-20t) is consumable.The single use combination cleaning brush (bw-412t) is for single use.Repeated usage of these brushes may cause the brush head to become bent or kinked, which could cause it to come off during use.Confirm that the brush is free from any damage or other irregularities before and after use." 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 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 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: 12615200
• MDR Text Key: 276428989
• Report Number: 8010047-2021-13046
• 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,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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: 09/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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