Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0723-05

Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01

Intuitive Surgical, Inc. / initiated 2005-03-09 / Terminated

Intuitive Surgical, Inc. began a recall of Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01 on . The reason FDA records is "Blades on the scissor may break and separate from the main unit as a result of corrosion damage". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0723-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Intuitive Surgical, Inc.
Product
Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
Product code
LRW Scissors, General, Surgical
Reason for recall
Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
FDA root cause
Other
Action
The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.
Quantity in commerce
278 units have been distributed.
Distribution
The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
Product codes and lots
FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.