Recall Z-0999-2022 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
| Date | Apr 22, 2022 (initiated Mar 17, 2022) |
| Status | Open, Classified |
| Reason | As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation. |
| Root cause | Under Investigation by firm |
| Action | On 03/17/2022, the firm sent an Urgent Medical Device Correction letter informing customers of a potential for injury associated with the stapler instruments if target tissue fails to remain in place with the jaws of the stapler during the stapler firing sequence. This phenomenon is referred to as a tissue pushout event. As the staple firing sequence progresses, the target tissue is transected but the target tissue is not approximated due to lack of staple engagement with the tissue. This type of event may result in un-approximated tissue and occurs when attempting to cross over existing stapl |
| Quantity | 6,8881 boxes (or 413,286 individual units/6 instruments/box) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The coun |
| FDA record | Open on fda.gov |