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

Model Number GIF-H290

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198); Failure to Clean Adequately (4048)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure when the foreign material adhered to the scope.Additionally, there was no delay in the start of pre-cleaning, the customer did flush the nozzle with water and air, they wiped the nozzle with clean lint-free cloths and submerged the device in detergent solution, and there were no abnormalities reported in the accessories used for reprocessing the device.The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, foreign material was discovered in the device nozzle.The customer's originally reported issues of a e315 scope error and no image were not confirmed.The following additional findings were also noted: dirt on the objective lens, discoloration of the connecting tube and bending section cover, wear of the angle wire causing bending angles in the up direction and play of the up/down knob to not meet the standard value, assorted chips, leakages, scratches, wrinkles, sticky components, slipping light guide bundle, shaved components, nozzle corrosion, objective lens discoloration, and loss of water tightness due to pinhole on the universal cord.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that their evis lucera elite gastrointestinal videoscope displayed a scope error e315 and the image would not appear.Upon inspection and testing of the returned unit, foreign material was found in the nozzle of the device.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions both initially reported as well as found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to b3.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 foreign material was insufficient cleaning.Identification of the material could not be determined.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: 16873466
• MDR Text Key: 314635581
• Report Number: 9610595-2023-07138
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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: 04/05/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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