daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.
- Company
- Intuitive Surgical, Inc.
- Recall Initiated
- July 1, 2019
- Recall Number
- Z-1891-2020
- Firm Location
- Sunnyvale, CA
Reason for Recall
The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
Distribution
Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands, Norway, South Korea, Spain, Switzerland, United Kingdom.
Lot / Code Info
Lot numbers: T10180615; T10180924; T10181003; T11181003; T10181010; T10181016; T10181029; T10181107; T10181109; T10181113
Root Cause
Employee error
Action Taken
On July 1, 2019 , the firm sent an "Urgent Medical Device Recall" notification to affected customers concer the da Vinci Xi SureForm 60 Stapler Reload. In addition to informing customer's about the recalled product, the firm asked customers to take the following actions: 1. Intuitive Surgical requests customers locate the affected Stapler Reloads at each site and return them. 2. Inform necessary personnel when corrective action has been completed. 3. If customer has distributed any affected product to other sites, please forward this notice to all related parties. 4. If available, please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 5. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form, or complete using the da Vinci online resource tool.