EEA EEAXL2835Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884523006148), received between Apr 17, 2017 and Jul 24, 2025 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE BEFORE PATIENT USE, THE CIRCULAR STAPLER DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585884 ↗
• MalfunctionJan 21, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY PROCEDURE FOR THE TREATMENT OF ISCHEMIC HEART DISEASE, AFTER FIRING FOR THE RECTAL ANASTOMOSIS, THE ANVIL HEAD FELL OVER OR COLLAPSED. WHEN EXTRACTING THE HANDLE, IT GOT CAUGHT STRONGLY, AND WHEN THE INTESTINAL TRACT WAS CHECKED AFTER REMOVAL, IT HAS TORN VERTICALLY BY ABOUT FIVE CENTIMETERS (CM). STARTING ONE CM ON THE ORAL SIDE OF THE ANASTOMOSIS AND EXTENDING APPROXIMATELY FOUR CM BEYOND THE ANASTOMOSIS ON THE ANAL SIDE. IT WAS COMPLETELY TORN INSIDE THE ABDOMINAL CAVITY TO THE EXTENT THAT THE RECTAL CAVITY WAS VISIBLE. THE DONUT RING HAS BEEN CONFIRMED WITHOUT ANY ISSUES, WITH THE ENTIRE CIRCUMFERENCE AND ALL LAYERS CHECKED ON BOTH THE ORAL AND ANAL SIDES. THE ANAL SIDE WAS DETACHED/MOVED FROM THE LACERATION PART, AND ADDITIONAL RESECTION OF SEVEN CM OF THE RECTUM AND ANASTOMOSIS WERE PERFORMED. THIS RESULTED IN SURGICAL TIME EXTENSION BY THREE TO FOUR HOURS. TO COMPLETE THE CASE, A NEW STAPLER WAS USED. A STOMA WAS NOT PLACED, AND THE POSTOPERATIVE PROGRESS WAS MONITORED.

  Patient problems: Failure to Anastomose; Laceration(s); Tissue Breakdown

  MAUDE report 21201348 ↗
• MalfunctionFeb 2, 2024Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A OPEN COLOSOTOMY REVERSAL, WHEN CREATING THE ANASTOMOSIS OF THE COLON, THE SURGEON FIRED (SQUEEZED) THE STAPLER TWICE, AND WHEN THE SURGEON FIRED (SQUEEZED) THE SECOND TIME, THERE WAS A LOUD CRACK AND THE TOP OF THE TILT TOP ANVIL BROKE OFF AND FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY THE SURGEON FROM THE ANAL CAVITY. IT WAS ALSO REPORTED THAT THE ANASTOMOSIS HAD A LEAK. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 18632086 ↗
• MalfunctionOct 18, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY DUE TO ADENOCARCINOMA OVER POLYP, AFTER FIRING WHEN REMOVING THE DEVICE, THE KNOB WAS TURNED TWICE TO OPEN THE ANVIL, AND THE ANVIL WAS ABLE TO TILT, HOWEVER THE INSTRUMENT REMAINED SNAGGED TO THE TISSUE. THE SURGEON HELPED TO CAREFULLY REMOVE THE DEVICE BY USING THEIR FINGERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961136 ↗
• MalfunctionAug 25, 2023Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC SIGMOID RESECTION, WHILE PERFORMING THE ANASTOMOSIS, THE CIRCULAR STAPLER WAS FIRED SUCCESSFULLY. HOWEVER, IT WAS SOMEWHAT DIFFICULT TO REMOVE THE STAPLER FROM THE PATIENT. UPON EXAMINATION OF THE STAPLER DONUTS, A MALFORMED OR UNFORMED STAPLE WAS IDENTIFIED. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE CIRCULAR STAPLER FIRE AND CLOSING WERE PERFORMED. THE DONUTS WERE COMPLETE, AND A LEAK TEST SHOWED SATISFACTORY RESULTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626397 ↗
• InjuryMar 6, 2023Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, ON THE SIGMOID COLON, THE FIRST STAPLER SAFETY PHYSICALLY BROKE. A SECOND ATTEMPT WITH A SECOND STAPLER WAS DONE AND IT CUT BUT DID NOT STAPLE. THE ANVIL FELL INTO THE PATIENT CAVITY. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE NOTED. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN ONE INCH. THE SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE AND REMOVE MORE TISSUE OF THE DISTAL STUMP TO RE-ANASTOMOSE TO RETRIEVE THE ANVIL BECAUSE NO STAPLES DEPLOYED. A CIRCULAR STAPLER FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF DIVERTICULAR DISEASE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16483981 ↗
• InjuryMar 3, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, ON THE SIGMOID COLON, THE FIRST STAPLER SAFETY PHYSICALLY BROKE. A SECOND ATTEMPT WITH A SECOND STAPLER WAS DONE AND IT CUT BUT DID NOT STAPLE. THE ANVIL FELL INTO THE PATIENT'S CAVITY. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE NOTED. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH. THE SURGEON HAD TO CONVERT TO AN OPEN PROCEDURE AND REMOVE MORE TISSUE OF THE DISTAL STUMP TO RE-ANASTOMOSE TO RETRIEVE THE ANVIL BECAUSE NO STAPLES DEPLOYED. A CIRCULAR STAPLER FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF DIVERTICULAR DISEASE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16479172 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANVIL DETACHED AT THE TIME OF FIRING. THE SURGEON USED ANOTHER FORCEPS TO RECOVER THE ANVIL THAT WAS IN THE COLON AND FINISHED THE SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15320528 ↗
• MalfunctionNov 16, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN LOW ANTERIOR RESECTION, THE WHITE PIN BROKE. A NEW DEVICE WAS OPENED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844035 ↗
• MalfunctionDec 18, 2019Device Slipped; Failure to Fire; Device Slipped; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOIDECTOMY, WHILE BEING APPLIED ON THE SIGMOID COLON, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL DID NOT CLOSE AND WAS THE GREEN BAR WAS NOT VISIBLE IN THE INDICATOR WINDOW. THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488393 ↗
• MalfunctionDec 11, 2019Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO END TO END ANASTOMOSIS DURING A LAPAROSCOPIC COLECTOMY, IT WAS STATED THAT THE ANVIL PREMATURELY TILTED WHEN SEATING CENTER SPIKE PRIOR TO FIRING STAPLER. A NEW STAPLER ANVIL WAS USED TO COMPLETE THE CASE. THERE AS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9455650 ↗
• InjurySep 29, 2019Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST OPERATIVELY, ON A LOW ANTERIOR RESECTION LAPAROSCOPY, THE PATIENT PRESENTED WITH AN ANASTOMOTIC LEAK THAT RESULTED IN A COLORECTAL LEAK AND A FAILED ANASTOMOSIS. THE PATIENT UNDERWENT A SECOND SURGICAL OPERATION TO REPAIR THE FAILED ANASTOMOSIS. THERE WAS TISSUE DAMAGE. THE PATIENT WAS HOSPITALIZED. ANOTHER PROCEDURE WAS DONE TO CLEAN THE AREA. THERE WAS A PATIENT INJURY.

  Patient problems: Bowel Perforation; Failure to Anastomose; Injury; No Code Available; Tissue Damage

  MAUDE report 9132551 ↗
• InjurySep 23, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING OPEN, LOW ANTERIOR RESECTION PROCEDURE, WHILE AN END TO END ANASTOMOSIS, THE SURGEON OBSERVED BUBBLES OF AIR FROM THE STAPLE LINE OF THE INITIAL ANASTAMOSIS BUT THE STAPLES DID FORM AND THE TISSUE WAS CORRECTLY CUT. OVER SEWED WAS DONE, THEN A SECOND DEVICE WAS OPENED AND ANOTHER ANASTAMOSIS WAS PERFORMED WHERE THERE DID NOT APPEAR TO BE A DISTAL DONUT. SURGICAL TIME WAS EXTENDED AND THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE REPORTED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9107760 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TWO DAYS FOLLOWING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE PATIENT BECAME SICK AND HAD TO GO BACK FOR ADDITIONAL SURGERY. THE PATIENT WAS GIVEN STOMA. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE. THE PATIENT HAD AN EXTENDED HOSPITALIZATION. THE PATIENT'S POST STOMA HAS NOT BEEN BOOKED YET.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8614011 ↗
• MalfunctionMar 25, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS IN AN OPEN COLOSTOMY PROCEDURE, THE DEVICE DID NOT FIRE. NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450076 ↗
• InjuryFeb 3, 2019Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLOSTOMY REVERSAL, AFTER THE STAPLER WAS FIRED THEY SAW AN OPENING IN THE ANASTOMOSES FROM 12 TO 6. THERE WAS POOR STAPLE FORMATION, THE HANDLE WAS FULLY SQUEEZED AND THE DONUTS WERE COMPLETE. THEY RESECTED, RE-STAPLED AND CONVERTED TO AN OPEN PROCEDURE TO FIX THE STAPLE LINE. THE ANVIL GOT STUCK ON THE ANASTOMOTIC LIP UPON REMOVAL. THE ANVIL CAN BE TILTED AFTER FIRING. THE EVENT LEAD TO OR EXTENDED THE PATIENT¿S HOSPITALIZATION. THEY NEEDED TO HAVE A COLOSTOMY FOR DIVERSION. THEY HAD TO EXCISE THE TISSUE TO CLOSE THE TISSUE DAMAGE.

  Patient problems: Failure to Anastomose; No Code Available; Tissue Damage

  MAUDE report 8300518 ↗
• InjuryDec 13, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLOSTOMY CLOSURE, WHILE CREATING THE ANASTOMOSIS, THE STAPLER MISFIRED. ANOTHER DEVICE WAS OPENED AND THE ANASTOMOSIS HAD TO BE REDONE RESULTING IN SURGICAL EXTENSION OF A FEW EXTRA HOURS. SURGEON HAD TO TRANSECT MORE OF BOWEL. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 8161208 ↗
• InjuryJul 25, 2018Failure to Form Staple; Activation, Positioning or Separation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROBOTIC SIGMOID COLECTOMY, ON SIGMOID COLON, THE DEVICE PARTIALLY FIRED. THE SURGEON FIRST USED OUR CIRCULAR STAPLER AND THE STAPLE LINE WAS INCOMPLETE. UPON SECOND ATTEMPT, THE SURGEON USED A COMPETITION'S CIRCULAR STAPLER AND STAPLE LINE WAS INCOMPLETE. ON THIRD ATTEMPT, THE SURGEON USED ANOTHER ONE OF OUR CIRCULAR STAPLER AGAIN AND STAPLE LINE WAS ALSO INCOMPLETE. UPON FOURTH ATTEMPT, THE SURGEON USED ANOTHER CIRCULAR STAPLER AND PERFORMED A SIDE TO END ANASTOMOSIS AND STAPLE LINE WAS COMPLETE. FLEXIBLE SIGMOIDOSCOPY REVEALED A PATENT WELL-PERFUSED ANASTOMOSIS, LEAK TEST WAS FINE AND DONUTS WERE GOOD. ON THE OUTSIDE, THEY HAD ENOUGH REDUNDANCY SO THAT THE COLON WAS REACHING WITHOUT ANY TENSION, BUT THE CUT END OF THE COLON WAS BLEEDING. HOWEVER, COLOPROCTOSTOMY WAS AT TEN CENTIMETERS FROM THE ANAL VERGE. A DIVERTING LOOP ILEOSTOMY WAS ALSO DONE TO PROTECT THE ANASTOMOSIS AND TO MITIGATE THE EFFECT OF ANY POTENTIAL LEAK IN THE FUTURE. THE ILEOSTOMY WILL BE RE-ANASTOMOSED IN THE FUTURE. THE SURGERY WAS EXTENDED BY THREE HOURS AND THE PATIENT STAYED IN THE HOSPITAL FOR SEVEN DAYS.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7718904 ↗
• InjuryMar 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, NINE DAYS AFTER A SIGMOID COLON RESECTION PROCEDURE, THE STAPLE LINE HAD A HOLE AND LEAKED. A WASHOUT PROCEDURE AND OVERSEW WAS DONE TO RESOLVE THE ISSUE AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED.

  Patient problems: No Code Available

  MAUDE report 7369652 ↗
• MalfunctionSep 28, 2017Failure To Adhere Or Bond; Human-Device Interface Problem; Failure To Adhere Or Bond; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, THE DEVICE WAS DIFFICULT OR UNABLE TO LOAD, ALSO THE WHITE TROCAR TIP WOULD NOT ATTACH TO THE STAPLER. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901532 ↗
• InjuryApr 17, 2017Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER: THE DONUTS WERE FULLY FORMED. THERE WERE TWO COMPLETE RINGS OF TISSUE. THE STAPLER CUT BUT THE STAPLES THEMSELVES DID NOT ENGAGE. THE PROCEDURE WAS CONVERTED TO A ROBOTIC LOWER ANTERIOR RESECTION. THERE WAS SOME TISSUE LOSS TO RE-DO THE ANASTOMOSIS AND RESECT ADDITIONAL RECTUM AND COLON. THERE WAS NO BLOOD LOSS OVER 500 CC. THE PROCEDURE WAS PROLONGED BY ABOUT SIXTY MINUTES DUE TO THE MISFIRE. THE CURRENT STATUS OF THE PATIENT IS FINE AND RECOVERED PER USUAL COURSE.

  Patient problems: No Code Available; Respiratory Distress; Tissue Damage

  MAUDE report 6498031 ↗