MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260

Device Problems Obstruction of Flow (2423); Device Damaged by Another Device (2915); Failure to Clean Adequately (4048)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, during reprocessing the head of the cleaning brush broke off in the channel tube (ch-tube).There is no patient involvement and no harm reported to any patient.The diagnostic gastroscopy procedure previous to the reprocessing was finished with the same device.

Manufacturer Narrative

This device is not sold in the us but a similar device is.The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that the head of the cleaning brush was clogged inside the suction tube.However, the broken piece could be removed from the device.There was no obvious resistance inside the suction tube that could catch the brush and break the head.The device nozzle was also found to be clogged with an unknown foreign material.The foreign material could not be removed.Other observations for the device are that flow from nozzle was not smooth due to clogging by foreign material and switch (sw) 1 was scratched.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.The brush that broke in the device is anrui¿s amh-qj2-0623.Customer provide information on reprocessing at the facility.The air water channel cleaning adapter is used for pre-cleaning, which is performed immediately after a procedure.Pre-cleaning steps are: wipe the insertion tube with enzyme lotion gauze; clean the dirt on the external surface of the endoscope; suction the enzyme lotion and air under negative pressure for 15 seconds respectively; and supply water and air for 15 seconds respectively.The endoscope channels are brushed during manual cleaning with anrui¿s amh-qj2-0623 reusable brush.Detergent and disinfectant solutions are amh-qj2-0623.Automatic endoscopy reprocessor (aer) being used to reprocess the endoscope is hongguang medical zlt-15wa.Detergent and disinfectant used with the aer is zlt-15wa.There are no issues with the aer.Once this device is reprocessed again, it will be stored in the mirror storage cabinet and hung.

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, the root cause of the reported event is unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15380521
• MDR Text Key: 305924133
• Report Number: 9610595-2022-01667
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2014
• 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