(b)(4).Initial report: dr (b)(6) deployed the bag to retrieve a specimen and the arms of the device reportedly went through the bag and lacerated the liver.This information is from the operating room director as the surgeon and the staff that were in the room at the time are unavailable during this reporting.From rep meeting on (b)(6) 2019 to gather additional details,: dr (b)(6) was a new user to the bag.I in-serviced and did case support (one case) prior to the event.His first assist, (b)(6), usually deploys the bag in the robotics cases; this was a right robotic-assisted laparoscopic partial nephrectomy.Operative report states the following: complications: deployment of the retrieval bag, prong lacerated the posterior liver 1 to 2 cm.Description of procedure: [?]."i then sharply excised the tumor and placed it in a retrieval bag, which at that point, the right prong when opened, then created a small posterior laceration to the liver, had a very small ooze.We proceeded to pay attention to the kidney , which was oozing more so than the liver.I placed the bag off to the side".[?]."in the meantime, i had placed floseal and surgicel over the liver.This was subsequently removed and evaluated.No active bleeding.I did place tisseel over it to assure no further bleeding as well as the right kidney." incident report filed by (b)(6), rn.The device is not available.
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