MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM OVERTUBE, TS-13140

Model Number	TS-13140
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The over-tube was requested for evaluation; however it was discarded by the customer.The customer indicated that this is the first incident like this at the facility.Review of manufacture records did not reveal any abnormalities.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2020 fujifilm medical systems usa (fmsu) was informed that during a double balloon endoscopy (dbe) procedure for anemia, a black piece of rubber was found in the patient's stomach; fmsu notified fujifilm corporation of the event on (b)(6) 2020.The material appeared to be the black seal on the ts-13140 (over-tube) which holds the balloon onto the over-tube.Upon further investigation, the customer clarified that the seal was found in the small intestine not the stomach as initially indicated; according to the nurse the band may have fallen off while the scope was entering the small intestine at the beginning of the procedure.The material was successfully removed from the patient with forceps.Upon removal of the scope from the patient the technician and nurse inspected the black seal and noticed that it seemed very soft and easy to peel off.There were no issues with the en-580t scope therefore it was never taken out of use.The procedure was completed with no adverse effects to the patient.The patient was discharged one hour after the procedure with no additional concerns.There was no serious injury or death associated with this event.This report is being submitted in abundance of caution.

• Brand Name: FUJIFILM OVERTUBE, TS-13140
• Common Device Name: OVERTUBE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 10083009
• Report Number: 3001722928-2020-00008
• Device Sequence Number: 11647648
• Product Code: FED
• UDI-Device Identifier: 04547410331516
• UDI-Public: (01)04547410331516(17)210930(10)1910A3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091773
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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 Model Number: TS-13140
• Device Catalogue Number: N/A
• Device Lot Number: 1910A3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1