Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Syst
FDA device recall Z-2020-2014 · posted 2014-07-08 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
- Action taken
- Urgent Medical Device Correction letters were sent on June 18, 2014 to all affected sites via trackable mail.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 5290 for part 420230-04; 1964 for part 420240-06
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-06-13
- Date posted
- 2014-07-08
- Date terminated
- 2014-12-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |