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

Model Number	GIF-XTQ160
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
Event or Problem Description
The customer reported to olympus, the gastrointestinal videoscope had a defective lens or camera.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the jet tube had foreign objects.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
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to the reportable findings documented in b5, non-reportable findings are as follows; the air water cylinder and suction cylinder had no color, due to wear of the angle wire the play of the up and down and right and left knobs were out of standard value, the adhesive on the bending section cover was detached, and the connecting tube had a scratch.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.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.   new information added to the following field: h6.Correction on field: d5, e1 (first name, last name, and address should remain blank, establishment name updated), e2, e3 and g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.   based on the results of the investigation, the root cause of the event was unable to be identified.It was confirmed that there was a foreign object attached to/clogged in the sub-water supply channel, but the foreign object could not be identified.It is unclear whether there was any deviation from the instruction manual in the reprocessing procedure for areas where foreign matter remained.No physical damage was observed where foreign matter remained.The detection method is described in the instruction manual evis exera gif type xtq160 operation manual chapter 3 preparation and inspection.Prevention measures are described in the instruction manual evis exera gif type xtq160 reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.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: 18025246
• Report Number: 9610595-2023-16037
• Device Sequence Number: 18096642
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: Other
• Device Model Number: GIF-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2012
• 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