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

Model Number	TS-13101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was submitted to the fda by the user under report number mw5148196.Fujifilm attempted to identify the facility for further investigation, but was unable to identify the facility.The cause of the malfunction could not be determined from the information provided in mw5148196.There was no injury to the patient reported.This report is being submitted in an abundance of caution.
Event or Problem Description
On (b)(6) 2023, fujifilm corporation was informed of an event involving ts-13101.It was reported that the seal at the top is not intact.There was no injury to the patient reported.

• 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: 18407520
• Report Number: 3001722928-2023-00065
• Device Sequence Number: 14121616
• Product Code: FED
• UDI-Device Identifier: 04547410331509
• UDI-Public: (01)04547410331509(17)240731(10)2208S8
• 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): 12/28/2023

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 Lot Number: 2208S8
• 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: 12/09/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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