EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si

FDA device recall Z-0074-2015 · posted 2014-10-16 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.

Action taken

Intuitive Surgical sent an Urgent Product Notice letter dated September 19, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: -Immediately stop using the EndoWrist Stapler 45 instrument. -Quarantine the EndoWrist Stapler 45 instruments within your hospital. Keep the instruments quarantined until Intuitive Surgical sends you a subsequent communication with instructions regarding the quarantined product. -Ensure all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, and members of your medical staff who perform da Vinci Si surgery procedures using the EndoWrist Stapler 45 instrument. -Please retain a copy of this notice for your records with your da Vinci Si User Manual. If you need further information or support concerning this Product Notice, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at 800-876-1310 Option 3 (6 am to 5 pm PST).

Root cause

Device Design

Status

Terminated

Product code

NAY

Quantity affected

1,034 Devices

Distribution

US Nationwide Distribution.

Date initiated

2014-09-18

Date posted

2014-10-16

Date terminated

2015-03-03

Location

Sunnyvale, CA

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