Device Recall STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit 의 리콜

Recall

76754

Class 2

Z-1716-2017

2017-03-15

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154111

Intuitive surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the is4000 stapler release kit instruction card may result damage of the tool.

Intuitive sent an Urgent Medical Device Correction (ISIFA2017-02-C) letter dated March 16, 2017 were sent by FED EX to be received on March 17, 2017. Letters advised users of the reason for the notification, risk to health, affected products with part numbers and a copy of Appendix A - proper use of the Stapler Release Kit (SRK). Customers were instructed to distribute a copy of the letter to all users at their facility, follow all instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and return the SRK to Intuitive Surgical through the Returned Material Authorization (RMA) process. Customers were also instructed to log into the da Vinci Online Community Field Action resource (US only) to read or complete any request actions related to this issue. In the case where the da Vinci online resource cannot be used (including outside he US), complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. Customers were asked to retain a copy of the letter with their Stapler User Manual and the acknowledgement form for their files. If you need further information or support concerning this notification , please contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.