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

Model Number	GIF-XP150N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.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 olympus representative reported that during a diagnostic upper endoscopy procedure, the gastrointestinal videoscope presented with a lateral noise that entered the octagonal screen of the endoscope during the procedure and displayed error code e311 (white balance not set).The endoscope screen had appeared and disappeared.There was a possibility that the contact on the scope cable was poor, so the user tried disconnecting and reconnecting the cable, but the issue did not improve.Therefore, when checked using a simple water leakage checker, it was found that air and water leakage bubbles were coming out of the scope connector stopper, and there was a gap.The procedure was cancelled.The customer confirmed there was no health hazard to the patient.
Event or Problem Description
Additional information was received from the customer.The procedure was for a screening test with no health hazard for the patient.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.
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.It has been more than 7 years since the subject device was manufactured.Based on the results of the investigation, water intrusion inside the scope likely caused moisture to attach to the circuit board of the electrical circuit board.As a result, a conduction abnormality such as a short circuit occurred.In addition, external stress likely caused the connecting section of the parts to break affecting the weather tightness of the device.However, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 15977277
• Report Number: 9610595-2022-05423
• Device Sequence Number: 6894983
• Product Code: FDS
• UDI-Device Identifier: 04953170307478
• UDI-Public: 04953170307478
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2023

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-XP150N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/23/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 12/16/2022; 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2015
• 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: Male