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

Model Number	GIF-2TH180
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a fine needle biopsy procedure set up for a suspected pancreatic mass, the suturing system (non-olympus) was placed in an olympus double channel scope, and it was discovered that the double channel scope had connectivity issues causing no image.The patient was already sedated and intubated at the time of malfunction.Due to no image issue the procedure was cancelled and rescheduled the next day and completed successfully with another scope and another suturing system.No further information is avaliable at the time of the report.

• 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
• MDR Report Key: 20746965
• Report Number: 2429304-2024-0000474
• Device Sequence Number: 8363015
• Product Code: FDS
• UDI-Device Identifier: 04953170339745
• UDI-Public: 04953170339745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2024
• Report Date (Section F): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVERSTITCH SUTURING SYSTEM, NON-OLYMPUS DEVICE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown