MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE

Model Number PCF-H290ZI

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

During the device evaluation, the air and water supply volumes did not meet the standard values due to foreign material in the nozzle.In addition, stretched angle wires caused the up/down knob and the up angle to be out of standard value.The a-rubber was chipped and cracked, with a white clouded area; the adhesive around the objective lens had a white clouded area; and the adhesive around the objective lens was peeled.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation, or if additional information is provided by the customer.

Event Description

A customer reported a problem with the air/water flow system of the evis lucera elite colonovideoscope.There were no reports of patient harm.The device was returned to an olympus repair facility for evaluation.During inspection and testing, foreign material was found clogging the nozzle.This medical device report (mdr) 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 established.The suggested phenomenon was confirmed - however, the foreign material in the nozzle was unable to be further specified.Moreover, no deformation of the nozzle was observed, nor was any obvious deviation of reprocessing.Therefore, the cause of the remaining foreign material could not be presumed from the obtained information.The inspection method for the event is described as follows in the operation manual "chapter 3 preparation and inspection 3.3 inspection of the endoscope and 3.8 inspection of the endoscopic system: "[inspection of the endoscope] 8.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.[inspection of the objective lens cleaning function] inspection of the water feeding function: 1.Keep the air/water valve¿s hole covered with your finger.2.Depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16986715
• MDR Text Key: 315923731
• Report Number: 9610595-2023-07887
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H290ZI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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