MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOACOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-LV1
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the gastrointestinal videoscope had a blurred image.The issue occurred during preparation for use.There were no reports of patient involvement or injury.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.The device was returned to olympus for inspection, and the customer's allegation regarding a blurry image was confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be due to internal components such as charged coupled device unit had an abnormality.There was no physical damage on outer surface of the subject device.The event can be detected and prevented by following the instructions for use which state: "chapter 3 preparation and inspection: the equipment prepared before using this endoscope and procedures for inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection: the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning: never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk." "chapter 5 troubleshooting: the countermeasures against troubles are described in this chapter.5.1 troubleshooting: if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide.¿ if the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair.¿ also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity.¿ warning: never use the endoscope on a patient if any irregularity is observed.The irregular endoscope may compromise patient or user safety and may result in more severe equipment damage.In addition, it may pose an infection control risk." olympus will continue to monitor field performance for this device.
Event or Problem Description
The intended procedure was a diagnostic gastroscopy, which was completed with another device.

• Brand Name: GASTROINTESTINAL VIDEOACOPE
• 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: 19506688
• Report Number: 9610595-2024-11680
• Device Sequence Number: 17998065
• Product Code: FDS
• UDI-Device Identifier: 04953170312373
• UDI-Public: 04953170312373
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2024

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-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/26/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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