MAUDE Adverse Event Report: FUJIFILM CORPORATION TS-13101 STERILE OVERTUBE; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	TS-13101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fujifilm investigated the manufacturing records for the lot in question and found no concerns.It was unable to identify the cause because fujifilm could not identify the facility where the malfunction occurred and could not obtain additional information.
Event or Problem Description
On april 1st, 2025, fujifilm corporation was informed of an event involving ts-13101 via medwatch report, mw5167672, from fda.It was reported that the distal end balloon of fujifilm ts-13101 overtube were found split on multiple occasions.Due to the unknown patient impact and adverse impact during the procedure, this report is being submitted in abundance of caution.

• Brand Name: TS-13101 STERILE OVERTUBE
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 21940969
• Report Number: 3001722928-2025-00017
• Device Sequence Number: 8547765
• Product Code: FED
• UDI-Device Identifier: 04547410331509
• UDI-Public: (01)04547410331509(17)260131(10)2402T4
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 01/31/2026
• Device Model Number: TS-13101
• Device Lot Number: 2402T4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown