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

Model Number	GIF-XTQ160
Medical Device Problem Codes	Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's allegation was not confirmed.In addition, the following non-reportable malfunctions were found during device evaluation: leak between right/left knob and up/down knob, leak at the electrical connector guide pin, and plastic distal end cover chipped.The investigation is on-going.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
The customer reported to olympus that the evis exera gastrointestinal videoscope had air/water duct defective.During inspection and evaluation, foreign materials were found inside the nozzle, at the objective lens adhesive and at the suction cylinder.At the suction cylinder and objective lens adhesive was found a brown parched foreign material.Inside the nozzle was found also the brown parched foreign material but mixed with white fibers.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during incoming inspection and evaluation.
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 of the event was unable to be identified.Adhesion of foreign matter to the joint of the objective lens was confirmed.Due to the water leakage that occurred in the equipment, it is likely that the reprocessing could not be performed properly and the foreign matter could not be removed.The detection method is described in the operation manual evis exera gif-xtq160 operation manual chapter 3 preparation and inspection and instruction manual evis exera gif/cf/pcf type 160 series reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures describes preventive measures.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: 17176571
• Report Number: 9610595-2023-09142
• Device Sequence Number: 17725501
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/02/2023

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: 05/31/2023
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2012
• 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