On (b)(6) 2012, dr.
(b)(6) at (b)(6) hospital in (b)(6) forwarded to intuitive surgical an article, titled robotic instrument insulation failure: initial report of a potential source of patient injury published by dr.
The article alleges that from (b)(6) 2008 - (b)(6) 2009, 12 mcs tip cover accessories, installed on the monopolar curved scissors instruments failed intra-operatively during da vinci robotic procedures and with 3 of the tip cover failures resulting in patient injuries.
The following details concerning the second patient injury as indicated in the article is as follows: during a da vinci urological procedure, while performing a retroperitoneal lymphadenectomy using the monopolar curved scissors instrument with the mcs tip cover installed, the patient's small bowel was injured.
Damage to affected area was recognized immediately and was repaired by reapproximation of the serosa using a silk suture.
Inspection of the tip cover accessory by the site found that the tip cover exhibited a hole at the junction of the silicon and gray plastic shaft on the tip cover.
Per the information indicated in the report, the tip cover accessory was inspected prior to use, was installed on the mcs instrument using the tip cover installation tool with no obvious mechanical imperfections observed in the tip cover.
No other details concerning the patient were provided.
Medwatch report 2955842-2008-01353 was submitted to the fda concerning the first patient injury and medwatch report 2955842-2012-01412 was submitted for the third report of a patient injury.