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

Model Number PCF-H290ZI

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

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

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the device was manufactured.The device was returned to an olympus repair facility, and an evaluation of the device was performed.Upon inspection and testing of the unit, residual fluid and foreign material came out of the channel tube, caused by insufficient cleaning, in addition, the clogged channel tube suction volume did not meet the standard value.The bending angle and the play of the up/down knob did not meet the standard values, caused by a worn angle wire.The bending angle in the up direction did not meet the standard value.The adhesive on the a-rubber was cracked.Switch 1 and the connecting tube had scratches, and the light guide lens had discoloration.Based on the obtained information, the root cause of the remaining foreign material could not be specified.This issue is addressed in the instructions for use (ifu): ¿chapter 3 preparation and inspection, 3.3 inspection of the endoscope and 3.8 inspection of the endoscopic system¿ describes the following warning.Inspection of the endoscope.1.Inspect the control section and the endoscope connector for excessive scratching, deformation, loose parts, or other irregularities.Inspection of the instrument channel.2.Insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also, make sure that no foreign objects come out of the distal end.3.Confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve.¿ olympus will continue to monitor the field performance of this device.

Event Description

A customer reported that ¿residual fluid or foreign matter comes out of the forceps channel¿ of the evis lucera elite colonovideoscope.There were no reports of patient harm.Upon inspection and testing, residual liquid and foreign material came out of the channel tube.This medical device report, (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17156894
• MDR Text Key: 318113592
• Report Number: 9610595-2023-09024
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• 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: 05/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• 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