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Zutron Medical
ZUTRON MEDICAL, L.L.C. · Model ZUTR162000 · UDI-DI 00817658020188
10
510(k) clearances
81,392
Adverse events (63 deaths)
25
Recalls
77
Facilities
Description
The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope Stiffening Device.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in tempera |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in |
| 2023-10-02 | Olympus Corporation of the Americas | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.