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

Model Number	GIF-XTQ160
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); 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 subject device was returned to olympus for evaluation.During inspection and testing, the allegations of washing not going through and a blockage were confirmed.The nozzle was clogged with a foreign material.In addition, lenses glue had a pin hole.Plastic distal end cover had a dent and scratch.The bending section cover glue was discolored.The bending section cover glue separated.The connecting tub was scratched.The universal cord had buckles.The air/water supply volume failed due to nozzle being clogged.Water contact/water removal failed due to nozzle being clogged.The play of angulation control knob was loose.The bending angle was reduced due to elongation of the angle wire.Device was reprocessed by using another company product.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A customer reported to olympus, washing does not go through the evis exera gastrointestinal videoscope.The connected hoses came loose and showed pressure being too high.The channels were brushed thoroughly but there may have been a blockage in one of the channels.The event occurred while in the dishwasher during reprocessing.The dishwasher beeped different errors each time.The leak test passed.The intended procedure was a gastroscopy that was completed successfully.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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, the root cause is unable to be determined and the foreign material could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 16433406
• Report Number: 9610595-2023-03128
• Device Sequence Number: 3126374
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K011151
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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