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

Model Number GIF-XP290N

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was cleaned, disinfected, and sterilized before requesting repair.The presence of foreign material adhering to the device was not known.Pre-cleaning information: there was no delay to the start of pre-cleaning which was done properly.Air/water nozzle was flushed with air/water.Information on manual cleaning: it¿s unknown if the accessories used for reprocessing were normal.Liquid was sent to the air/water nozzle and flushed with detergent solution.The air/water nozzle was wiped/brushed with clean lint free brush/cloth/sponges.The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, due to wear of angle wire, bending angle in up direction did not meet the standard value, nozzle had foreign objects, due to wear of angle wire, the play of up/down knob out of the standard value, angle rubber scratched, adhesive on angle rubber chipped, adhesive on angle rubber had white-clouded area, image guide protector scratched, protector of universal cord on control section side scratched, adhesive around objective lens peeled, adhesives around objective lens had white-clouded area, and connecting tube scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A user facility submitted a repair request to the olympus service center, for an evis lucera elite gastrointestinal videoscope, having insufficient angle.Upon inspection and testing of the returned device, foreign material was found clogged in the scope nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

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 identity and definitive root cause of the foreign material could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Keep the air/water valve¿s hole covered with your finger and 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 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 (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: 16886126
• MDR Text Key: 314735264
• Report Number: 9610595-2023-07197
• Device Sequence Number: 1
• Product Code: FDS
• 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,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP290N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• 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