3 0 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • A P R I L 2 0 1 9
I
t's no secret that a
stapler failure can
quickly turn a
routine procedure into
an emergency. What's
surprising is the
alarming number of
times staplers have
misfired or failed to
fire — and the number
of patients that have
been harmed or killed
as a result. Over the
last 7 years, malfunc-
tioning surgical staplers have seriously injured more than 9,000
patients and killed 366 others, according to an analysis by the U.S.
Food and Drug Administration, which last month sent healthcare pro-
fessionals a letter warning them of the dangers (osmag.net/rAcBP5).
From Jan. 1, 2011, to March 31, 2018, the FDA says it received
reports of more than 32,000 stapler and staple malfunctions. Among
the most commonly reported problems: the opening of the staple line
or malformation of staples; misfiring; difficulty in firing; failure of the
stapler to fire staples; and misapplied staples (user applying staples to
the wrong tissue or applying staples of the wrong size to the tissue.)
Stapler and staple malfunctions could result in prolonged surgical
procedures or unplanned additional surgical interventions which may
lead to complications, such as bleeding, sepsis, fistula formation, tear-
FDA Shocked by Spike in Malfunctioning Staplers
Devices that misfired or failed to fire have injured or killed thousands.
Mike Morsch | Associate Editor
• IN THE LINE OF FIRE The FDA is concerned by the increasing number of adverse
events associated with surgical staplers and staples.
Stephen
Moyer