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

Model Number GIF-Q260

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, cracked on illumination lens due to an external factor, scratches on the insertion tube, insertion tube discolored, wrinkles in the insertion tube, curved rubber adhesive missing, foreign object inside nozzle, scratches found on tip cover, water tightness of switch 4 not maintained, scratches found on the switch box, air and water supply cylinders corroded, image shows forceps flare, ghosting allowed in the image, scratches found on the operation part, discoloration of the operation part recognized, scratches on the operation unit cover, scratches on the up/down knob, scratches on the up/down angle fixing lever, up/down knob corroded, scratches found on the right/left knob, scratches found on the grip, scratches found on the universal cord, scratches on the scope connector side of the universal cord, water coverage recognized on the electrical connector, scratches found on the scope connector, scope connector corroded, and scratches on the right/left angle fixing knob.The faulty parts will be replaced, and the device will be 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 gastrointestinal videoscope having poor air/water supply, and water on lens.Upon inspection and testing of the 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

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 observed foreign material clogging the scope air/water nozzle could not be identified and the root cause of the issue could not be determined, as there was no deformation observed that might contribute to the retention of foreign material and the device reprocessing was confirmed to have been implemented in accordance to the ifu.The event can be detected/prevented by following the instructions for use sections below: ¿chapter 3 preparation and inspection, 3.2 inspection of the endoscope and 3.6 inspection of the endoscopic system¿ describes the following warning¿.¿9.Inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities¿.¿1.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¿.Reprocessing survey info: - the device was cleaned, disinfected, and sterilized before being sent to olympus - the air/water nozzle was flushed with water and air - there were no abnormalities in the accessories used for reprocessing - the air/water nozzle was wiped/brushed with clean lint free cloths, brushes, or sponges - the air/water nozzle was flushed with detergent solution olympus will continue to monitor field performance for this device.

Event Description

Additional event information received from the customer: the event was noticed during inspection for use.The procedure was diagnostic.The procedure was completed using another 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 (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: 16708349
• MDR Text Key: 313199828
• Report Number: 9610595-2023-05881
• 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: 06/06/2023

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-Q260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2009
• 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