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

Model Number CF-H190I

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the reported issue was not confirmed.During inspection, a white stringy material, whose origin could not be identified was found partially clogging the hose nozzle.Electrical safety checks were performed, and it was noted that the insulation distal end (d/e) resistance value was out of specification.It was also noted that the distal end light guide rod lens was cracked, the bending section cover glue was worn out, and one defective pixel was noted which later was fixed.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.

Event Description

The customer reported to olympus, the suction valve of the evis exera lll colonovideoscope was observed to be stuck after an unknown procedure.The device was immediately reprocessed after the procedure.The device had been leak tested and had passed.The device had been inspected prior to the procedure and no abnormalities were found.The procedure was completed with the same device.There was no reported delay that was considered clinically relevant.Upon inspection and testing of the device, a clogged nozzle was found, which had been attributed to insufficient cleaning.There was no harm or user injury reported due to the event.This report is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

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 determined.However, it is likely that gauze with lint was used for reprocessing, the lint entered the air/water channel and clogged in the nozzle.The following is included in the instructions for use (ifu) and may have helped prevent the event: "inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities" "all cloths used in reprocessing are recommended to be lint-free.Lint or cloth fibers shed into reprocessing fluids may be injected into the endoscope channels.There is the potential for lint or cloth fibers to lodge in channels or become trapped in the air/water nozzle.If gauze is used to reprocess the endoscope, ensure that fibers do not get caught on or remain trapped by protruding components like the air/water nozzle." " clean the external surface"."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 EXERA LLL 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: 14343004
• MDR Text Key: 299854486
• Report Number: 8010047-2022-07929
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305177
• UDI-Public: 04953170305177
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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