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EEA STAPLER MALFUNCTION
• Various studies have proven staplers are superior
to hand sewn anastomosis especially in colorectal
cases
• Important to remember that these devices have a
failure rate
• Device failures can cause major morbidity and
mortality
• The incidence rates of primary stapler
malfunction ranged from 0.022% to 2.3%
• Till 2019, 366 deaths were recorded from
malfunction in US
• A surgical stapling device can fail either because
of device malfunction.
• Defined as when the device fails to meet its
performance expectations (excluding user errors)
• Or improper use of the device (user error).
• An example of device malfunction- faulty stapling
cartridge incompletely loaded with staples during
manufacture.
• example of stapling failure- improper use, using a
stapling cartridge meant for thin tissue on thick
tissue.
• Stapling devices require user familiarity and
competence.
• Based on the literature, manufacturing errors
leading to device malfunctions are rare.
• The most commonly reported faults are staple
misfires
• These can lead to incomplete, absent, or poorly
formed staples.
• Can lead to unplanned conversion to open
surgery to control the situation.
Staplers malfunction
• Staples were malformed
• Cut but did not fire staples
• Misfire and did not open OR unable to
disengage
• Cut and only partially stapled
• Complications associated with the EEA stapler are
primarily postoperative, involving anastomotic
leak or stricture.
• Intraoperative problems mainly include
• Bleeding
• Leak
• Difficult insertion or extraction
• Stapler misfire- results in an incomplete
doughnut separation, the device becomes
trapped intraluminally
Our experience
• 42 year young male with diagnosis of FAP
• Planned for laparoscopic total proctocolectomy
with ileo rectal anastomosis
• Dissection carried out with ease
• Rectal transection done by linear gold stapler
• Pouch created by linear white stapler
• End to end ileal pouch to rectal anastomosis by
circular EEA stapler
• Stapler misfired- cut but did not staple
? How to manage
• No space to fire another stapler at rectal end
• Hence EEA not an option
• Approach – Ileal pouch anal anastomosis-
Hand sewn
• Other scenario- if AR or higher level
transection
• Refire linear stapler across colon/ rectum
• Use another EEA Stapler
The staple line appeared intact and tension free
but unable to disengage the device from the
anal canal.
• Approach - open the stapler intraluminally
• extraction of the main component without the
anvil
• sigmoidoscopy
• Using a hot biopsy forceps release the
doughnut tissue without disturbing the staple
line
• Incidence of post operative anastomotic leak-
3-23 %( 4.4% stapled, 8.4 % hand sewn)
If stapler misfire , partial stapled
• Air leak test positive
(1) Repair/ Reinforce anastomosis with suture without diversion
(2) Proximal diversion
(3) Takedown of anastomosis with new anastomotic construction and no
diversion.
(4) Surgical sealant with or without diversion
If air leak testing yielded positive results, suture repair alone was associated
with the highest rate of postoperative clinical leak compared with diversion or
reanastomosis, 12.2% vs 0% vs 0%, respectively
Ricciardi R, Roberts PL, Marcello PW, Hall JF, Read TE, Schoetz DJ. Anastomotic Leak Testing After
Colorectal Resection: What Are the Data? Arch Surg. 2009;144(5):407–411.
doi:10.1001/archsurg.2009.43
Step wise approach
• Assess and manage the acute issue- bleeding
control, prevention of contamination
• Assess options on how to achieve the same
outcome as was intended or a suitable
alternative
• Get help
Prevention
• Be familiar with stapler, read instructions
carefully
• Choose correct stapler size
• Confirm correct purse string suture taken, anvil
snugly fit before firing staple
• Avoid stapling over clips and crotch staples
• Inspect the tissues and stapler prior to firing
• Report all cases of malfunction to the authority
Thankyou

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stapler misfire.pptx

  • 2.
  • 3. • Various studies have proven staplers are superior to hand sewn anastomosis especially in colorectal cases • Important to remember that these devices have a failure rate • Device failures can cause major morbidity and mortality • The incidence rates of primary stapler malfunction ranged from 0.022% to 2.3% • Till 2019, 366 deaths were recorded from malfunction in US
  • 4. • A surgical stapling device can fail either because of device malfunction. • Defined as when the device fails to meet its performance expectations (excluding user errors) • Or improper use of the device (user error). • An example of device malfunction- faulty stapling cartridge incompletely loaded with staples during manufacture. • example of stapling failure- improper use, using a stapling cartridge meant for thin tissue on thick tissue.
  • 5. • Stapling devices require user familiarity and competence. • Based on the literature, manufacturing errors leading to device malfunctions are rare. • The most commonly reported faults are staple misfires • These can lead to incomplete, absent, or poorly formed staples. • Can lead to unplanned conversion to open surgery to control the situation.
  • 6. Staplers malfunction • Staples were malformed • Cut but did not fire staples • Misfire and did not open OR unable to disengage • Cut and only partially stapled
  • 7. • Complications associated with the EEA stapler are primarily postoperative, involving anastomotic leak or stricture. • Intraoperative problems mainly include • Bleeding • Leak • Difficult insertion or extraction • Stapler misfire- results in an incomplete doughnut separation, the device becomes trapped intraluminally
  • 8. Our experience • 42 year young male with diagnosis of FAP • Planned for laparoscopic total proctocolectomy with ileo rectal anastomosis • Dissection carried out with ease • Rectal transection done by linear gold stapler • Pouch created by linear white stapler • End to end ileal pouch to rectal anastomosis by circular EEA stapler • Stapler misfired- cut but did not staple
  • 9. ? How to manage • No space to fire another stapler at rectal end • Hence EEA not an option • Approach – Ileal pouch anal anastomosis- Hand sewn • Other scenario- if AR or higher level transection • Refire linear stapler across colon/ rectum • Use another EEA Stapler
  • 10. The staple line appeared intact and tension free but unable to disengage the device from the anal canal. • Approach - open the stapler intraluminally • extraction of the main component without the anvil • sigmoidoscopy • Using a hot biopsy forceps release the doughnut tissue without disturbing the staple line
  • 11.
  • 12. • Incidence of post operative anastomotic leak- 3-23 %( 4.4% stapled, 8.4 % hand sewn)
  • 13. If stapler misfire , partial stapled • Air leak test positive (1) Repair/ Reinforce anastomosis with suture without diversion (2) Proximal diversion (3) Takedown of anastomosis with new anastomotic construction and no diversion. (4) Surgical sealant with or without diversion If air leak testing yielded positive results, suture repair alone was associated with the highest rate of postoperative clinical leak compared with diversion or reanastomosis, 12.2% vs 0% vs 0%, respectively Ricciardi R, Roberts PL, Marcello PW, Hall JF, Read TE, Schoetz DJ. Anastomotic Leak Testing After Colorectal Resection: What Are the Data? Arch Surg. 2009;144(5):407–411. doi:10.1001/archsurg.2009.43
  • 14. Step wise approach • Assess and manage the acute issue- bleeding control, prevention of contamination • Assess options on how to achieve the same outcome as was intended or a suitable alternative • Get help
  • 15. Prevention • Be familiar with stapler, read instructions carefully • Choose correct stapler size • Confirm correct purse string suture taken, anvil snugly fit before firing staple • Avoid stapling over clips and crotch staples • Inspect the tissues and stapler prior to firing • Report all cases of malfunction to the authority