MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM OVERTUBE TS-13140; ENDOSCOPIC ACCESS OVERTUBE

Model Number TS-13140

Device Problem Inflation Problem (1310)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

This device is a single-use product, but the failure occurred at the third time of reuse.Reprocessing and repeated use of single-use products may be a cause of failure.

Event Description

Double balloon endoscopy was performed, to diagnose abdominal pain.After the endoscope reached the small intestine, the overtube became trapped in the small intestine, making insertion difficult.During removal of the overtube along with the endoscope, bleeding was observed, in the small intestine and esophagus.The patient was admitted for observation.The balloon of the overtube that was removed had moved to the distalend side and failed.There was only a small amount of air remaining in the balloon.

• Brand Name: FUJIFILM OVERTUBE TS-13140
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE
• 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; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538 ; JA 258-8538
• MDR Report Key: 18927592
• MDR Text Key: 337945828
• Report Number: 3001722928-2024-00009
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 14547410357131
• UDI-Public: (01)14547410357131(17)250904(10)2309S1
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TS-13140
• Device Lot Number: 2309S1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian