(b)(4) upon receipt, the hercules device, lot number 10223, released for sale in 2009, was visually and functionally inspected pursuant to specific atricure investigation procedures.The quick connect mechanism was missing from device.All links of the device were still attached by the cable.
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A patient underwent a undetermined surgical procedure on (b)(6) 2022.As the hercules ii arm was being tightened, the staff felt and heard a snap.The surgical team noticed that pieces from the hercules arm fell into the patient¿s chest.The links were removed from patient manually and an x-ray was completed to confirm all parts had been removed.Upon evaluation of the device by atricure, it was determined that the quick connect mechanism had separated from the device.This was a device malfunction and no patient adverse event was reported.
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