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

Model Number	GIF-N180
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the evaluation found that the probe cover, objective and light guide lens had foreign material.The air water cylinder and scope cylinder had no color, switch 1 had a scratch, the up down knob had corrosion, the scope identity data malfunctioned causing radio frequency identification data to not be read.The label on the scope connector id damaged, the scope connector had corrosion, the electrical connector had a stain, the connecting tube had a pinhole losing water tightness, the distal end had a crack, the scope probe cover had a scratch, the objective lens has a crack, the universal cord has a wrinkle and the protector of the universal cord on the scope connector side had a scratch.The customer later confirmed that that they cleaned, disinfected, and sterilized the product before returning it for evaluation.Additionally, there was no delay in the start of pre-cleaning, the nozzle was flushed with water and air, there were no abnormalities reported in the accessories used for reprocessing the device, and the customer wiped/brushed the air/water nozzle with lint free cloths, brushes, or sponges.The customer also flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing of the device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the gastrointestinal videoscope exhibited the probe cover, objective and light guide lens had foreign material.There were no reports of patient involvement.
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 found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is like, that the event reported as "foreign material" was caused by a reprocessing was not conducted properly, due to leakage from insertion tube.The event can be detected/prevented, by following the instructions for use, which state: ifu states, that detection method in evis exera ii, gif/cf/pcf type 180 series, operation manual chapter 3: preparation and inspection.Ifu states, that preventive measure in evis exera ii, gif/cf/pcf type 180 series, reprocessing manual chapter 5: reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.

• 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: 19148965
• Report Number: 9610595-2024-08316
• Device Sequence Number: 7833733
• Product Code: FDS
• UDI-Device Identifier: 04953170339080
• UDI-Public: 04953170339080
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2007
• 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