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

Model Number GIF-EZ1500

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported, the gastrointestinal videoscope had mucosal debris in the endoscope (operating channel).The issue occurred during an unspecified procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

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 reported mucosal tissue in the forceps was not confirmed during inspection and evaluation of the device, and a definitive root cause of the issue could not be determined, as there was no deformation observed that might result in the retention of tissue and no additional event or reprocessing information was reported or available, however, it is likely that the reported issue was the result of: a) while collecting mucosa multiple times during a procedure, the mucosa partially ran out from the cup of the forceps and got caught in biopsy channel or internal valve of biopsy port, and lodged there.When the forceps were inserted afterwards, the lodged mucosa adhered to the tip of the forceps and was visible in the scope image; or b) if mucosal tissue was collected from a previous case and comes out, it likely remained adhered in the forceps channel after reprocessing; when the forceps were inserted during the case, the tissue was visible in the endoscopic field of view.The issue may be detected/prevented by following the instructions for use which state: operation manual chapter 5 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¿.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18898962
• MDR Text Key: 337650489
• Report Number: 9610595-2024-05379
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-EZ1500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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