EEA EEAXL31Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884523006162), received between Sep 15, 2017 and Feb 10, 2026 — classified as 19 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (11 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION (AR) OPEN PROCEDURE WITH COLON ANASTOMOSIS, THE INSTRUMENT DID NOT FIRE. THE SURGEON REPLACED THE DEVICE WITH ANOTHER CIRCULAR STAPLER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309005 ↗
• MalfunctionNov 21, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A STAGE IV ENDOMETRIOSIS WITH SEGMENTAL RESECTION OF THE RECTUM, IN RECTOSCOPY, FOLLOWING THE FIRING OF THE MICHELIN TEST (BUBBLE TEST), SOME PART OF THE STAPLE LINE DOES NOT HAVE A STAPLE. TO RESOLVE THE ISSUE, AN ABSORBABLE SUTURE WAS USED ON THE ANTERIOR TRACK OF THE COLO-RECTAL ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 23621703 ↗
• InjuryNov 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN ENDOMETRIOSIS PROCEDURE, THE STAPLER LINE WAS NOT CONTINUOUS AND HAD TO BE REPLACED WITH A SUTURE. IT WAS NOTED THAT THE PATIENT HAD AN ACUTE COMPLICATION OF LOCALIZED PERITONITIS ANASTOMOSIS FISTULA THREE DAYS LATER. TO RESOLVE THE ISSUE, AN ADDITIONAL PROCEDURE WAS DONE FOR TEMPORARY LATERAL COLOSTOMY.

  Patient problems: Failure to Anastomose; Peritonitis; Tissue Breakdown

  MAUDE report 23596818 ↗
• MalfunctionNov 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A STAGE IV ENDOMETRIOSIS WITH SEGMENTAL RESECTION OF THE RECTUM, IN RECTOSCOPY, AFTER FIRING THE DEVICE AND WHILE PERFORMING THE BULLET TEST (MICHELIN TEST), SOME PART OF THE STAPLE LINE DOES NOT HAVE A STAPLE. TO RESOLVE THE ISSUE, AN ABSORBABLE SUTURE WAS USED ON THE ANTERIOR TWITCH OF THE COLO-RECTAL ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 23596699 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A DEFECTIVE BLADE WAS ASSOCIATED WITH THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21698110 ↗
• MalfunctionMar 4, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLECTOMY, THE CIRCULAR STAPLER RESECTED THE PROXIMAL AND DISTAL ENDS OF THE COLON, BUT THERE WAS NO ANASTOMOSIS THAT HAPPENED AS THE STAPLES DID NOT FORM PROPERLY. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 21516464 ↗
• MalfunctionJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, AFTER FIRING THERE WAS STAPLE LINE BLEEDING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19596561 ↗
• MalfunctionFeb 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE DID NOT ACTIVATE. IT DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793862 ↗
• MalfunctionNov 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE BODY AND THE ANVIL COULD NOT BE ASSEMBLED. A NEW ADDITIONAL DEVICE WAS USED. THERE WAS NO PATIENT INV OLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213085 ↗
• MalfunctionJul 19, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE CIRCULAR STAPLER WAS FIRED TO PERFORMED ANASTOMOSIS, MALFORMATION OF STAPLE HAS OCCURRED.

  Patient problems: Failure to Anastomose

  MAUDE report 17354001 ↗
• MalfunctionJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN AIR LEAK TEST, LEAKAGE WAS FOUND AFTER THE ANASTOMOSIS.

  Patient problems: Insufficient Information

  MAUDE report 17186463 ↗
• MalfunctionMay 26, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE STAPLE DID NOT COME OUT. THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015165 ↗
• MalfunctionOct 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE DID NOT FIRE. NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15601585 ↗
• MalfunctionAug 19, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CARTRIDGE BROKE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259082 ↗
• InjuryJul 1, 2022Failure to Form Staple; Material Twisted/Bent; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Material Twisted/Bent; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS OF A LAPAROSCOPIC LEFT COLECTOMY VISCERAL SURGERY, THERE WAS POOR STAPLE FORMATION, THE ANVIL WAS BENT. THERE WAS UNANTICIPATED TISSUE LOSS AND DAMAGE. THE SURGEON RESECTED AND RE-STAPLED TO FIX THE STAPLE LINE AND REDO THE ANASTOMOSIS MANUALLY THAT RESULTED IN INTRAOPERATIVE CONTAMINATION TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 14892152 ↗
• MalfunctionMay 16, 2022Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DEVICE DID NOT CUT TISSUE. THE KNIFE DID NOT GO THROUGH AND STOPPED THE CARTRIDGE.

  Patient problems: Insufficient Information

  MAUDE report 14414332 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING END-TO-END ANASTOMOSIS FOR  LAPAROSCOPIC SIGMOID COLECTOMY, STAPLE LINE LEAK WAS OBSERVED ON THE ANASTOMOSES FROM 2 DEVICES. A COLOSTOMY WAS MADE. THE EVENT LED TO TISSUE LOSS. SURGICAL TIME WAS EXTENDED BY AT LEAST 30 MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 12821231 ↗
• InjurySep 29, 2021Failure to Cut; Difficult to Open or Close; Failure to Cut; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING ROBOTIC SIGMOIDECTOMY WHICH WAS CONVERTED TO OPEN, THE DEVICE PARTIALLY CUT THE TISSUE. THE WING NUT TURNED 1.5 INSTEAD OF 2 WHEN OPENING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12551074 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT HEMICOLECTOMY, THE DEVICE WAS ABLE TO FIRE WITH NO PROBLEMS, HOWEVER TWO DAYS AFTER SURGERY THERE WAS AN ANASTOMOSIS DEHISCENCE. TO RESOLVE THE CONCERN THE PATIENT HAD TO UNDERGO AN OPEN RE-OPERATION. DUE TO THE DEVICE ISSUE, THERE WAS TISSUE DAMAGE AND BLOOD LOSS OCCURRED, IN ADDITION THE PATIENT EXTENDED HOSPITAL STAY AND A TEMPORARY COLOSTOMY WAS NEEDED.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12543296 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY COLORECTAL PROCEDURE, THE DEVICE WAS ABLE TO FIRE WITH NO PROBLEMS, HOWEVER TWO DAYS AFTER THE SURGERY THERE WAS AN ANASTOMOSIS DEHISCENCE AND IT WAS DIAGNOSED ON A STOOL IN DRAIN. TO RESOLVE THE CONCERN, THE PATIENT HAD TO UNDERGO AN OPEN RE-OPERATION. DUE TO THE DEVICE ISSUE, THERE WAS TISSUE DAMAGE AND BLOOD LOSS OCCURRED, IN ADDITION THE PATIENT EXTENDED HOSPITAL STAY AND TEMPORARY COLOSTOMY WAS NEEDED. THE PATIENT ALSO EXPERIENCED DEHYDRATION, FEVER AND INFECTION.

  Patient problems: Dehydration; Failure to Anastomose; Fever; Hemorrhage/Blood Loss/Bleeding; Post Operative Wound Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12542793 ↗
• InjuryApr 14, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE DID NOT STAPLE ALL THE WAY BUT IT CUT SO IT LEFT A HOLE IN THE STAPLE LINE. THE STAPLE LINE WAS INCOMPLETE AND IT WAS REPORTED THAT SOME OF THE STAPLES WERE NOT PROPERLY FORMED. IN ADDITION, IT WAS REPORTED THAT THERE WAS EXTRA TISSUE ON THE METAL RING PORTION AND THERE WERE TWO STAPLES IN THERE. THE HOLE IN THE STAPLE LINE WAS OVERSOWN AND THE SURGEON COMPLETED THE DIVERSION AFTER THE ANASTOMOSIS DID NOT PASS THE VISUAL INSPECTION. THE PATIENT IS STILL IN HOSPITAL. THE PATIENT IS REPORTING PELVIC PAIN; HOWEVER, CAUSE IS CURRENTLY UNKNOWN.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 11667844 ↗
• InjuryOct 14, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A RESTORATION OF COLON CONTINUITY PROCEDURE, THE STAPLER CUT, BUT DEPLOYED ONLY HALF OF THE STAPLES ON THE COLON. THE SURGEON SUTURED THE INCOMPLETE STAPLE LINE AND CREATED AN ILEOSTOMY. THERE WAS TISSUE DAMAGE AND TISSUE LOSS DUE TO THE REPORTED EVENT. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES. THE PATIENT WILL ALSO BE SUBJECTED TO ANOTHER SURGERY TO RESTORE THE CONTINUITY OF THE COLON. THE PATIENT EXPERIENCED EXTENDED HOSPITAL STAY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10676627 ↗
• MalfunctionAug 18, 2020Loss of or Failure to Bond; Material Twisted/Bent; Loss of or Failure to Bond; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLORECTAL ANASTOMOSIS, THE PIN OF THE ANVIL OPEN RARELY AND CONNECTOR BENT AND NEVER LOAD THE STAPLER. THE SURGEON THEN USED ANOTHER DEVICE 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 10420344 ↗
• MalfunctionJul 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION, THE ANVIL OF THE FIRST STAPLER WAS BENT IN THE BOX AND WAS NOT USED IN THE CASE. A SECOND STAPLER WAS OPENED AND USED INSTEAD. AFTER FIRING THE SECOND STAPLER, THE SURGEON REMOVED IT FROM THE RECTUM OF PATIENT BUT THE ANVIL DISENGAGED FROM THE STAPLER AND STAYED INSIDE THE PATIENT. THE SURGEON USED GRASPERS TO RETRIEVE THE ANVIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347742 ↗
• MalfunctionJul 21, 2020Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, THE METAL PRONGS WERE OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10303407 ↗