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FUJIFILM TS-13140Recalls & reported problems

Fujifilm Corporation · These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547410331516), received between May 22, 2020 and May 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 22, 2020Material Fragmentation; Material Fragmentation

    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 I

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10083009 ↗

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Sources and updates

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