It was reported by the rep that the (1) cdh33 was used during a lower anterior resection procedure. It was reported that the instrument did not fire properly. The staple line "donuts" were incomplete. The case was finished by hand-suturing. There was no consequence to the pt.

Sent 08/25/1999. A1,2,3,4; b6,7; d10; e1: info not provided during initial contact. Batch no: m4de6g, lot no: m4dn0h, qty invld: 1, warranty: no. Question and result: damaged anvil/anvil shroud, no; damaged guide face, no; damaged trocar, no; tissue present/describe, no; b/a washer present/condition, present/uncut; safety release, good; 1st fire-setting/form/heights, high b/good; 2nd fire-setting/form/heights, n. A; returned staples-heights, n/a; missing parts, no; damaged knife, no; damaged staple pockets, no; damaged other, no; staples present/location, no; trocar/anvil fit, good; indicator response, good; 1st fire-washer cut, good; returned staples-#/form, n. A. ; and other(non-circ. ) staples, n/a. Visual comment: the instrument was received with the breakaway washer uncut but with an indentation around the entire circumference. Functional comment: the instrument was reloaded with staples and a breakaway washer and fired. It fired and formed all the staples as well as completely cut the test media. Analysis conclusion: the instrument was received with the breakaway washer uncut. It appears that the instrument was not fired through a complete firing stroke. This is evidenced by the breakaway washer being returned uncut but with a slight indentation around the entire circumference. It should be noted that to ensure the instrument has been fired through the complete firing stroke, the trigger must be fully actuated. A tactile feedback will be felt when the breakaway washer has been fully cut. This will ensure proper formation of the staples and a complete cut of the tissue. The instrument was reloaded and fired. It fired and formed all the staples as well as completely cut the test media and the breakaway washer.