FUJIFILM TS-13101Recalls & reported problems
Fujifilm Corporation · This product is used in combination with a FUJINON/FUJIFILM Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. Never use this product for any other purposes. This product is not intended for use for any child or baby. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547410331509), received between Nov 15, 2023 and May 1, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Break; Break
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940969 ↗MalfunctionMay 1, 2025Break; Break
ON APRIL 1ST, 2025, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING TS-13101 VIA MEDWATCH REPORT, MW5167671, 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21940968 ↗MalfunctionDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18407520 ↗MalfunctionNov 15, 2023
SEAL AT THE TOP IS NOT INTACT. FUJIFILM OVERTUBE TS-13101.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150812 ↗
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- Trokamed WA2PS18LTROKAMED GmbH · Endoscopic Access Overtube, Gastroenterology-Urology1 recall0 reports
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- Navigator HD M0062502220Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology1 death31 reports
- Navigator HD M0062502230Boston Scientific Corporation · endoscopic access overtube, gastroenterology-urology29 reports
- Proxis™ Ureteral Access Sheath 231045C. R. Bard, Inc. · endoscopic access overtube, gastroenterology-urology22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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