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

Model Number	GIF-H180J
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In addition to the phenomena identified in b5, the following phenomena were also identified during evaluation: there was a leak in the biopsy channel, and there were tears on the biopsy channel wall.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the gastrointestinal videoscope had a blurry image.The issue was found during an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation a definitive root cause could not be determined.The event can be prevented by following the instructions for use which state: chapter 3 preparation and inspection before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 5.3, ¿returning the endoscope for repair¿ on page 99.Warning: using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.Chapter 5 troubleshooting if the endoscope is visibly damaged, does not function as expected, or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope.Contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 5.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair.Warning: never use the endoscope on a patient if an irregularity is observed.Damage or an irregularity in the instrument may compromise patient or user safety and may result in more severe equipment damage.Should any irregularity in the function of the endoscope and/or endoscopic image be observed during use, stop the examination immediately and carefully withdraw the endoscope from the patient as described in section 5.2, ¿withdrawal of the endoscope with an irregularity¿ on page 97.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported the procedure was diagnostic.

• 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: 18611914
• Report Number: 9610595-2024-02053
• Device Sequence Number: 16736518
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2010
• 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