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

Model Number	GIF-Q260J
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Company representative sent repair request reported with an issue of "chemical adhesion".The issue found during an unknown event.No harm was reported.No patient harm, no user injury reported due to the event.Device evaluation found the device connecting tube has foreign material.This report is being submitted for foreign matter adhered (problems related to reprocessing, insufficient reprocessing ).
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation found the device connecting tube has foreign material.The angle wires were stretched.Due to wear of angle wire, bending angle in up direction does not meet the standard value.Adhesive on a-rubber (bending section) has a chip, crack.Adhesive has white-clouded area.Universal cord noted dirty (handling issue).Connecting tube has coating peeling.Scratch noted on the device other parts (control unit, knobs, grip, protector of universal cord on control section side (due to external factors, handling issue ).Based on the device evaluation finding foreign material adhered on the device connecting tube , likely this is attributed to the reported phenomenon ("chemical adhesion" ) due to handling, reprocessing issue.Investigation however, is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to b3, h4.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 of the foreign material was insufficient cleaning.Identification of the material could not be determined.The event can be detected/prevented by following the instructions for use which state: ¿[inspection of the endoscope].3.Inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, holes, sagging, transformation, bends, adhesion of foreign bodies, dropout of parts, any protruding objects or other irregularities.4.Holding the insertion tube gently with one hand, carefully run the fingertips over the entire length of the insertion tube in both directions (see figure 3.2).Confirm that no object or protrusion of metallic wire around the insertion tube is stopping the hand.Also confirm that the insertion tube is not abnormally rigid.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 16040378
• Report Number: 9610595-2022-06014
• Device Sequence Number: 6437617
• Product Code: FDS
• UDI-Device Identifier: 04953170307492
• UDI-Public: 04953170307492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2022
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2005
• 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