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

Model Number	GIF-XP180N
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported to olympus, the evis exera ii gastrointestinal videoscope had a blurry image.The subject was unable to be recognized and the image did not return.The issue was found during preparation for use.There were no reports of patient harm.
Event or Problem Description
The customer reported to olympus, the evis exera ii gastrointestinal videoscope had a blurry image.The subject was unable to be recognized and the image did not return.The issue was found during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation (h6/h10).The device was returned to olympus for inspection, and the customer's complaint was confirmed.There was a shadow on the image due to a crack in the objective lens.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 could not be determined.It is likely the event was caused by physical stress that was applied during user handling.The event can be detected by following the instructions for use (ifu) which state: "- inspection of the endoscopic image".The event can be prevented by following the instructions for use (ifu) which state: "- inspect the external surface of the entire insertion section including the bending section and the distal end for any irregularities such as dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, and protruding objects.- do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." in addition, the following non-reportable malfunctions were found during the device evaluation; there was restriction in the both the forceps and brush passge channel due to buckle/dent in the insertion tube, the angulation was below standard, and the control knob showed play in the up/down knob.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: 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: 16357308
• Report Number: 9610595-2023-02281
• Device Sequence Number: 12499455
• Product Code: FDS
• UDI-Device Identifier: 04953170275425
• UDI-Public: 04953170275425
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIF-XP180N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown