Recall Z-2328-2020 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Intuitive Surgical, Inc.
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
| Date | Dec 19, 2019 |
| Status | Terminated |
| Reason | Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes. |
| Root cause | Device Design |
| Action | The firm sent a Field Safety Notice, titled Urgent Medical Device Correction Letter - ISIFA2019-10-C to customers via FedEx starting on December 19, 2019. The letter informed customers that the firm had received complaints regarding small but detectable holes in the sterilization wrap used with da Vinci Xi 8 mm Endoscope Sterilization Trays (PN 400498-02) and Handheld Camera Sterilization Trays (PN 400499-03). Customers were informed that certain features on the trays, in combination with loading and unloading of wrapped trays into sterilizers, and stacking and unstacking of wrapped trays dur |
| Quantity | 1757 Trays |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183139 | Endoscope Sterilization Tray Intuitive Surgical, Inc., Feb 1, 2019 |