STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45,
FDA device recall Z-2675-2016 · posted 2016-08-26 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
- Action taken
- Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South America: 800-876-1310, option 3 (6AM to 5PM PST) Email: customersupport..servicesupport@intusurg.com Europe, Middle East, Asia and Africa Phone: 800-821-2020 or +41 21 821 2020 Email: ics@intusurg.com Customers were also instructed to complete the attached Return Acknowledgement Form and submit via email to Regulatory Compliance at isi.compliance@intusurg.com or by fax to +1 (408) 523-0619. For questions regarding this recall call 408-523-2100. 10-31-16 Update: Monthly status update states that an additional 93 instruments have been identified and an additional communication will be sent to these sites in Mid November 2016,
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 875 instruments (827 a la carte + 48 in kits) total, all models
- Distribution
- Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
- Date initiated
- 2016-07-14
- Date posted
- 2016-08-26
- Date terminated
- 2017-01-03
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS (K140553) | Intuitive Surgical, Inc. | 2014-07-25 |