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

Model Number GIF-H260Z

Device Problem Image Display Error/Artifact (1304)

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

Event Date 10/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegations was confirmed.The evaluation found that due to a pinhole on air/water tube, water tightness is lost; and due to damage on coupled charging device (ccd) unit, the image is not displayed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the evis lucera gastrointestinal videoscope, had a blurry image.The event was found during reprocessing.The procedure was unknown.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

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, the air water (a/w) channel leaking during usage led to humidity entering the objective (ob) lens unit resulting in the image becoming blurred.The event can be averted by following the instructions for use (ifu) sections 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.

• 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: 18030866
• MDR Text Key: 326865055
• Report Number: 9610595-2023-16093
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H260Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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