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

Model Number GIF-H290

Device Problem Partial Blockage (1065)

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

Event Date 12/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the complaint device shows: the user's report of: "air or water flow is weak or ineffective" was not confirmed.The user's report of damaged of damaged switch one is confirmed.The key top of switch one was scraped and leaking.The user's report of clogged nozzle is confirmed.The nozzle was clogged with foreign material and could not support sufficient air/water pressure.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during reprocessing, it was discovered the number one button was damaged and the nozzle was clogged on an evis lucera elite gastrointestinal videoscope.Upon inspection and evaluation of the device, olympus noted that the nozzle was clogged with foreign material.The nozzle was replaced with a new one.There was no patient impact related to this occurrence.

Manufacturer Narrative

Correction: h4.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.Based upon the information provided via investigation, the cause was presumed to be an accessory of the device (water container, air/water valve, cleaning tool, etc.) was damaged, and a broken piece entered into the air/water channel.From the results of inspection, it was determined that, although the user reprocessed the subject device, the nozzle was still clogged.Within the instructions for use (ifu) of the unit, inspection for accessories is required.If users follow the ifu, the user can detect irregularities and can prevent using a device with irregularities.The following is provided within the ifu on the decrease/prevention of the suggested event: "to prevent clogging of the air/water nozzle of the endoscope, flush water into the air channel of the endoscope, using the channel cleaning adapter after each patient procedure." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 13232398
• MDR Text Key: 286352423
• Report Number: 8010047-2022-01254
• 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
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2018
• 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