MAUDE Adverse Event Report: FUJIFILM HEALTHCARE AMERICAS CORPORATION OVER-TUBE; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	TS-13101
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Seal at the top is not intact.Fujifilm overtube ts-13101.

• Brand Name: OVER-TUBE
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM HEALTHCARE AMERICAS CORPORATION
• MDR Report Key: 18150812
• Report Number: MW5148196
• Device Sequence Number: 17747513
• Product Code: FDF
• UDI-Device Identifier: 04547410331509
• UDI-Public: 010454741033150917240731102208S8
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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 Expiration Date: 07/31/2024
• Device Model Number: TS-13101
• Device Catalogue Number: EC-450BI5
• Device Lot Number: 2208S8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown