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

Model Number	GIF-2TH180
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The additional evaluation findings are as follows: the air/water cylinder had no color, the suction cylinder had no color, the grip had a scratch, the up/down knob had discoloration, the auxiliary water inlet was deformed, the electrical connector had corrosion due to water leakage, due to a burn on the plastic distal end cover, insulation resistance value value at the distal end did not meet standard value, due to wear of the angle wire, the play of the "up/down' and "right/left" knob was out of standard value, the adhesive on the bending section cover, around the objective lens and light guide lens had a white clouded area, and the universal cord had a wrinkle.
Event or Problem Description
The customer reported to olympus, the threaded connection of the flushing channel on the gastrointestinal videoscope has broken off.The device was returned for evaluation.During the device evaluation, foreign material was found in the jet tube.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 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, the root cause could not be determined.The foreign material could not be identified and the cause of the material remaining in the device could not be specified.There was no damage to the area where the foreign material was detected and it is unknown if reprocessing was performed according to the instructions for use (ifu).The event can be detected and prevented by handling the device in accordance with the following ifu: evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 "preparation and inspection" shows how to detect the event.Evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 "reprocessing of the endoscope (and related reprocessing accessories)¿ shows how to prevent the event.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: 18388084
• Report Number: 9610595-2023-20281
• Device Sequence Number: 11456341
• Product Code: FDS
• UDI-Device Identifier: 04953170275463
• UDI-Public: 04953170275463
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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-2TH180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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