It was reported that (1) device and (2) reloads were used during a gastrectomy. It was reported by the affiliate that the tct75 instrument misfired on each of the (3) firings with only half of the staples in each cartridge fired. The safety tab on all the trt75 reloads were present and correctly removed before inserting into the tct75 device. There was no consequence to the pt.

Sent: 08/09/1999. Reload cartridge-b. A1,2,3,4; b6,7; d10: info not provided by affiliate. D6: device returned with no lot indentification. Question and result: instrument halves: joined/separated, separated; hook latch position: open/closed, closed; cartridge position: not loaded; cartridge batch number: m4dd0t; swing tab position: locked/unlocked, locked; staples present? formed/unformed, in down drivers; staples form properly, yes; instrument safety lockout properly, yes; firing knob position: back/partial, forward; cam position: engaged/disengaged, engaged; knife condition: nicked; gapspace pin condition: good; drivers present in cartridge, prox 1 up; staples fire properly, yes; and staple heights conforming, na. Visual comment: the instrument was received with two mismatched halves. The anvil half was returned with batch number m4d38t and the cartridge half was returned with batch number l4cr4j. There were a total of three cartridges returned. A-batch number m4dd0t, b-batch number k47w5c, c-batch number m4d41v. Cartridge-a-see above. Cartridge b-the swing tab was locked and the proximal 1 driver was up with staples present in the down drivers. Cartridge c- was received with 3/4 of the drivers up with staples in the down drivers. The wing was broken on the proximal end of the cartridge. Functional comment: the swing tabs were reset and the cartridges were fired with the returned instrument. All fired and formed the remaining staples without incident. Analysis conclusion: the instrument was received with two mismatched halves. The instrument was also received with the knife nicked. There were three cartridges returned. The first and second cartridges were received with the swing tab locked and with the proximal drivers up. There were staples present in the down drivers. It appears possible that an inadvertent movement of the firing knob may have contributed to the reported incident. This is evidenced by the proximal drivers being in the up position and the lock out being in the locked position. It should be noted that the cartridge is designed to lock-out if any staples have been fired from the cartridge. However, it could not be determined if this may have occurred in this instance. The third cartridge was received with 3/4 of the drivers up. It was also noted that the cartridge was damaged. Based on the damage to the cartridge along with the nicked knife, it appears as if an attempt may have been made to fire the instrument across a hard object. The swing tabs were reset on the returned cartridges. The cartridges were then fired and formed the remaining staples outside without incident. Batch no: k47w5c, lot no: unk, qty invld: 2, warranty: no.