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

Model Number	GIF-XTQ160
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts to retrieve additional information from the customer are in progress.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and the results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported that the gastrointestinal videoscope tested positive for an unexpected contamination.The issues were found during regular examination in the hospital.The user did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide results of device evaluation.During device evaluation at olympus, it was found there was remains of a white foreign material in the jet tube and scope cover, the cover plate was deformed, the switch box was discolored, the air/water and suction cylinders had no color, the right/left and up/down knobs were discolored, the base plate, electrical connector and scope connector had corrosion due to water leakage, the insulation resistance value at the distal end did not meet the standard value due to adhesive peeling on the bending section cover, illumination was uneven due to dirt on the light guide lens, the play of the up/down knob did not meet the standard value due to wear of the angle wire, the light guide bundle was broken, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on results of third-party testing and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023.Sampling from: tip.Cfu: no detection.Bacterial identification: n/a.Sampling from: forceps channel/suction channel.Cfu: 0cfu.Bacterial identification: n/a.Sampling from: air/water channel.Cfu: 0cfu.Bacterial identification: n/a.Sampling from: sub-water channel.Cfu: 0cfu.Bacterial identification: n/a.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 and because the user culture results were not shared, the reported event could not be confirmed and a root cause could not be determined.Growth of microorganisms were reported through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.Additionally, a foreign object was confirmed in the sub-water supply channel and the plastic distal end cover, 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.There was no physical damage to the area where foreign matter remained.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." 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: 18253273
• Report Number: 9610595-2023-18601
• Device Sequence Number: 6571672
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2024

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-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• 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: 11/05/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 12/22/2023
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 12/08/2023; 01/05/2024
• 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