FDA (Devices) recall action 72036

Intuitive Surgical, Inc. recalled 9 products on 2015-09-16

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2015-09-16
Critical: 0
Units: 89,502

Why these products were recalled

In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers
Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.
Product
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in a
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SevereFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments
Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by train
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Crocodile Graspers
Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.
Product
Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers
Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.
Product
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained ph
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System
Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System
Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicia
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System
Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained p
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SevereFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers
Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in
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HighFDA (Devices)··2015-09-16
Intuitive Surgical Recalls da Vinci Si Maryland Bipolar Forceps
Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained phys
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