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

Model Number CF-HQ290L

Device Problems Partial Blockage (1065); Contamination (1120)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and foreign debris was found protruding from the air/water nozzle.The adhesives on the light and optical cover glasses were worn and the glass was chipped and scratched.The outlet pipe and air channel were both blocked, causing the subject device to fail testing associated with water flow/removal.The adhesive on the distal end was lifting, the insertion tube had minor marks, the up, down, and right angulation tests failed and play was evident.The device also failed the leak test.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer¿s olympus sales representative reported to olympus, the evis lucera elite colonovideoscope failed in the automatic endoscope reprocessor because of a restricted channel, which had caused high pressure during reprocessing.The intended procedure was completed with the subject device.There was no procedural delay associated with this event.There were no error codes displayed.During the inspection of the returned device, the evaluation found debris inside one of the channels.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

Corrected data: g2 (added other ¿ united kingdom).This report is being supplemented to provide additional information based on the legal manufacturer's investigation, the device history record (dhr) review and applicable corrections.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the investigation, it is likely the event was caused by a brush that was broken while brushing the air/water valve during reprocessing after the previous procedure.A bristle would have entered the air/water channel and clogged the nozzle.This is evidenced by the bristle type material found in the air/water nozzle during the inspection of the device.Users can detect the event by handling the device in accordance by following the instructions for use (ifu).Users are instructed to inspect 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.¿ users are instructed to inspect the endoscopic system: ¿inspection of the air-feeding function.Inspection of the objective lens cleaning function.¿ to reduce/prevent the event, the users should refer to the handling methods outlined in the ifu.The ifu instructions users of the following: ¿check bristles for loose or damage.Since brush is for single use, repeated usage may cause brush head to come off.Appropriate brushing method of a/w valve.¿ the reprocessing manual provides users with the following instructions on inspecting reprocessing accessories.¿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." "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.If a piece of the brush comes off inside the endoscope channel, immediately retrieve it.Confirm that no parts remain inside either the instrument channel or the suction channel of the endoscope by carefully passing a new brush through both channels.Any part left in the channels can drop into the patient during a subsequent patient procedure.Depending on the location of the missing part, the part may not be retrievable by passing a new brush.In this case, contact olympus.¿ olympus will continue to monitor the field performance of 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: 12657862
• MDR Text Key: 281660316
• Report Number: 8010047-2021-13348
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 09/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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