Reported Nov 6, 2013 · Terminated
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 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 an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.
- Lot codes and dates
- Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot #Batch/Lot #
63 of 63 codes
S10130510S10130325S10130314S10130314S10130415S10130426S10130329S10130228S10130418S10130304S10130418S10130325S10130325S10130408S10130408S10130510S10130415S10130304S10130314S10130415S10130418S10130228S10130329S10130329S10130415S10130426S10130426S10130426S10130408S10130325S10130228S10130325S10130426S10130426S10130418S10130325S10130510S10130408S10130415S10130408S10130228S10130304S10130418S10130415S10130426S10130314S10130426S10130418S10130228S10130228S10130304S10130415S10130415S10130418S10130408S10130329S10130314S10130228S10130228S10130314
S10130426S10130418S10130408S10130325S10130415S10130415S10130415S10130418S10130325S10130325S10130329S10130325S10130314S10130329S10130426S10130314S10130408S10130329S10130426S10130426S10130325S10130415S10130426S10130426S10130325S10130325S10130325S10130329S10130329S10130408S10130415S10130408S10130408S10130415S10130415S10130418S10130426S10130415S10130325S10130408S10130418
- Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot #
- Amount recalled
- 286 boxes ( 6 instruments per box) for a total of 2,220 affected clinical product
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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