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

Model Number	GIF-XP180N
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 to olympus for evaluation and the customer¿s allegation was not confirmed.During the evaluation it was found that foreign materials were found at the scope connector, distal end, objective lenses, and nozzle of the device.Additional evaluation findings were as follows: the switch box has a dent, the air/water cylinder, the suction cylinder both has no color, due to a cut on heat shrinking tube of lock engagement lever, expected insulation capacity cannot be obtained, due to dirt on objective lens, the image has a stain, the distal end has discoloration, and the connecting tube has a buckling.It is most likely that the reported issue was due to mishandling.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the evis exera ii gastrointestinal videoscope had loose and poor angles.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: foreign materials were found at the scope connector, distal end, objective lenses, and nozzle of the device.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the ¿whitish foreign material at distal end, nozzle, objective lens, suction connector¿ was confirmed.It could not be specified what the foreign material was nor the root cause of the remaining foreign material.However, it was confirmed that there was no deformation on the section of the device with the foreign material.It was confirmed that the reprocessing steps were implemented in line with the instructions for use (ifu).There was no report that the device was used for procedure while the event occurred.Performance of reprocessing on the device was secured in the reports by reprocessing appropriately in accordance with instructions for use.(ifu/cleaning/disinfection/sterilization).A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the device was manufactured.The suggested events can be detected and prevented by handling the device in accordance with the following instructions for use (ifu): ¿ 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: 17840844
• Report Number: 9610595-2023-14289
• Device Sequence Number: 4401818
• Product Code: FDS
• UDI-Device Identifier: 04953170339097
• UDI-Public: 04953170339097
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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-XP180N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2009
• 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