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

Model Number	GIF-H180J
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the gastrointestinal videoscope exhibited foreign material exiting from the air/water nozzle and nozzle was clogged with adhesive removal.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and evaluated.In addition to the malfunctions documented in b5, the additional evaluation findings were as followed: distal end plastic cover had dent/scratches, bending section cover was cracked on both sides, objective lens had tiny edge chip/scratches/worn, light guide lens was worn, switch/camera required cut 1 and 3, insertion tube was scratched, control body was missing cylinder color ring, scope connector had a loose auxiliary inlet, light guide prong/mount had scratches on cover glass, angulation wire were stretched, control knob movement was recommended and all labels were recommended.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
Correction to information provided in the initial report: it was reported, the gastrointestinal videoscope nozzle was clogged.The issue occurred during reprocessing.There were no reports of patient harm.This report is not being submitted to report the malfunction found during device evaluation, as was previously reported in the initial medwatch report.
Additional Manufacturer Narrative
This report is being supplemented to correct information that was provided in the initial medwatch report and to provide additional information based on the legal manufacturer's final investigation.Correction to information provided in g3 of the initial medwatch report: g3 - date of awareness should be jan 22, 2024.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over thirteen (13) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause for the unidentified foreign material clogged in nozzle could not be determined since no physical damage of the device was confirmed at where the foreign material was remained and whether there was deviation from instructions for use in reprocessing steps were not confirmed.The event can be detected/prevented by following the instructions for use which state: instructions for use states the detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Instructions for use states the preventative measures 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: 18664902
• Report Number: 9610595-2024-02706
• Device Sequence Number: 17910119
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2010
• 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