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

Model Number	GIF-XP190N
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The gastrointestinal videoscope was returned as part of the asset return process.During routine inspection of the device by olympus, white foreign material was found within the air/water (a/w) cylinder.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned to olympus as part of the asset return process.Upon evaluation, besides the reportable malfunction of white foreign material in the a/w cylinder, the following non-reportable malfunctions were identified: water tightness was lost due to a crack on the scope cover, deformation of right/left knob, and deformation of up/down knob; switch 1 and 2 were cut; there was no color on the a/w cylinder; grip was shaved; forceps channel port had a dent; due to water leakage there was corrosion on base plate, plug unit, cable unit, scope connector case, and circuit board unit in scope connector; damage on scope connector, cover of charged coupled device, and instrument guide protector; deformation of connecting tube and universal cord; and evidence of third party repair.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issues.It has been over 6 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation and the available information, the foreign material could not be identified, and likely remained due to insufficient reprocessing.However, a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu): the ifu states the detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.The ifu states the preventative measures in gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA LLL 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: 18243371
• Report Number: 9610595-2023-18476
• Device Sequence Number: 7116652
• Product Code: FDS
• UDI-Device Identifier: 04953170436772
• UDI-Public: 04953170436772
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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-XP190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2017
• 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