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

Model Number GIF-H290

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

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, bending angle insufficient due to the elongation of the angle wire, play of the angle knob out of the normal state due to the elongation of the angle wire, curved pipe deformed due to external factors, scratches on the insertion tube due to external factors observed, wrinkles in the insertion tube, curved rubber adhesive missing, due to handling (insufficient cleaning), the air and water nozzles clogged and the draining function reduced, foreign object inside nozzle, scratches found on the tip cover, insertion tube oredome broken, watertightness not maintained due to wear of up/down knob, strange noise from the up/down knob, scratches on the up/down knob, scratches on the up/down angle fixing lever, scratches on the right/left angle fixing knob, air and water supply cylinders corroded, objective lens missing, scratches found on the operation part, discoloration of operation part, switch 4 worn out, scratches found on the switch box, suction cylinder scraped, scratches on the operation unit cover, scratches found on the right/left knob, scratches found on the grip, scratches are found on the universal cord, scratches on the scope connector side of the universal cord, scope connector corroded, scratches found on the scope connector, scratches on the scope connector cover, peeling of the paint recognized on the air/water supply cylinder, and peeling of paint is recognized on the suction cylinder.The faulty parts were replaced, and the device was returned to the user facility.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 poor air/water supply.Upon inspection and testing of the customer returned device, foreign material was found clogged in the scope air/water 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

Correction to 10, the user provided information regarding the reprocessing of the subject device where the subject device was cleaned, disinfected and sterilized before being sent to olympus.The user did not have any knowledge of when the foreign material adhered to the endoscope or what the foreign substance was.There was no delay in the start of pre-cleaning.The air/water nozzle was flushed with water and air.It was unknown if there was any abnormalities in the accessories used for reprocessing.The air/water nozzle was wiped/ brushed with clean lint free cloths brushes or sponges.No information was received on if the air/water nozzle was flushed with detergent solution.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 foreign material could not be identified and a definitive root cause could not be determined.The following is included in the instructions for use (ifu): "inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities." "inspection of the objective lens cleaning function"."inspection of the water feeding function"."1 keep the air/water valve¿s hole covered with your finger.2 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: 16530603
• MDR Text Key: 311576790
• Report Number: 9610595-2023-04179
• 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: 04/19/2023

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: 02/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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