EEA EEA33Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10884523005561), received between Mar 29, 2017 and Sep 30, 2026 — classified as 3 deaths, 48 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (42 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951331 ↗
• MalfunctionJun 12, 2026Device Slipped; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER CLOSED BUT DID NOT LOCK AND THUS, UNABLE TO FIRE. THE DEVICE WAS WOBBLY AND LOOSE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25483187 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, UPON APPROXIMATING OR CLOSING THE STAPLER, THE ANVIL DID NOT ATTACH OR REMAIN ATTACHED TO THE CENTER-ROD OF THE STAPLER. THE ANVIL DISENGAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629490 ↗
• MalfunctionJan 2, 2026Failure to Form Staple; Misassembly by Users

  IT WAS REPORTED THAT DURING USE, THERE WERE STAPLE FORMATION ISSUE, DEFORMITY IN STAPLE LINE FORMATION, AND A MISMATCH BETWEEN THE ANVIL AND THE RELOAD. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23952590 ↗
• InjuryNov 27, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTUM RESECTION, THERE WAS AN INCOMPLETE STAPLE LINE, AND A STAPLE FORMATION ISSUE WHERE SOME STAPLES DID NOT FORM PROPERLY OR DID NOT FORM AT ALL. AS A RESULT, THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES, THE PROFESSOR NEEDED TO SUTURE AS A REPLACEMENT FOR THE STAPLE LINE, AND IT WAS NECESSARY TO CUT INCORRECTLY FORMED STAPLES AND AFTER THE ISSUE, THE PROCEDURE WAS CONVERTED TO COLOANALIS ANASTOMOSIS PROCEDURE.

  Patient problems: Failure to Anastomose

  MAUDE report 23667628 ↗
• MalfunctionNov 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ABDOMINAL RECTOSIGMOIDECTOMY, WHEN THE SURGEON ATTEMPTED TO STAPLE THE INTESTINE, THE INSTRUMENT DID NOT FIRE. THE MATERIAL WAS SUBSTITUTED WITH ANOTHER ONE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477429 ↗
• MalfunctionOct 16, 2025Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING AN ENDOMETRIOSIS PROCEDURE, THE STAPLER STOPPED WHEN CLOSING TO FIRE, AND THE GREEN INDICATOR DID NOT APPEAR. THE SURGEON DECIDED TO OPEN AND DISCONNECT THE WOUND. THE SURGEON NOTICED THAT IT HAD TURNED EVEN WITHOUT FIRING FOR STAPLING. THE DEVICE WAS REMOVED, AND THE SAME TYPE OF CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311303 ↗
• MalfunctionJul 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING USE OF THE CIRCULAR STAPLER, AN INCOMPLETE STAPLE LINE (PARTIALLY FIRED) OCCURRED. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22542856 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO HAVE A PART BROKEN UPON OPENING, WHICH MADE USAGE IMPOSSIBLE. THE DEVICE WAS NEVER IMPLANTED AND NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22231370 ↗
• MalfunctionApr 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE CIRCULAR STAPLER, THERE WERE ISSUES RELATED TO THE STAPLE LINE. THIS RESULTED IN EXTENDED SURGICAL TIME. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 21865600 ↗
• MalfunctionDec 5, 2024Device Slipped; Failure to Form Staple; Mechanics Altered; Device Slipped; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT THE MITG SURGICAL INNOVATIONS CIRCULAR STAPLER PRESENTED FIXED ROTATION BEFORE STAPLING, WHICH DID NOT ALLOW FOR COUPLING AND ADJUSTMENT. ADDITIONALLY, THERE WERE FIRING ISSUES WITH THE EEA, RESULTING IN AN INCOMPLETE STAPLE LINE AND INSTANCES WHERE STAPLES DID NOT DEPLOY, CUTTING BUT NOT STAPLING. THE PATIENT EXPERIENCED NO CONSEQUENCES OR IMPACT FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 20858125 ↗
• MalfunctionSep 27, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LOW ANTERIOR RESECTION, AFTER FIRING THE STAPLER ON THE PATIENT'S BODY, THE STAPLE LINE DID NOT FORM CORRECTLY ON THE TISSUE. TO RESOLVE THE ISSUE WITH THE STAPLE LINE, THE DOCTOR FIRED A NEW STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 20327485 ↗
• MalfunctionSep 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129030 ↗
• InjuryJul 1, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Firing Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE TREATMENT OF DEEPLY INFILTRATING ENDOMETRIOSIS, DESPITE PROPER INSTALLATION AND THE APPEARANCE OF THE GREEN INDICATOR, WHEN THE STAPLER WAS FIRED, THERE WAS A VERY HIGH RESISTANCE, WHICH PREVENTED FULL COMPRESSION OF THE HANDLE. THERE WAS A DEFORMATION OF THE STAPLES AND A BLOOD LOSS OF 200ML. A SECTION OF THE INTESTINE WAS CUT OFF AND ANOTHER CIRCULAR STAPLER FROM THE SAME BATCH WAS USED WITH NO PROBLEM. DUE TO THE DEVICE ISSUE, THE PATIENT WAS FITTED WITH A TEMPORARY PROTECTIVE STOMA FOR THREE MONTHS. SURGICAL TIME WAS EXTENDED FOR AN HOUR.

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

  MAUDE report 19644423 ↗
• MalfunctionJun 10, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY, AFTER STAPLING, THE DOCTOR OBSERVED THAT THE STAPLE LINE WAS INCOMPLETE AND THAT PART OF THE ANASTOMOSIS HAD REMAINED OPEN. A RE-STAPLING WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19498433 ↗
• MalfunctionJun 4, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 19461796 ↗
• MalfunctionMay 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL WAS CLOSED, AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW, BUT THE DEVICE 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 19353722 ↗
• MalfunctionFeb 28, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18804110 ↗
• InjuryFeb 28, 2024Device Slipped; Failure to Align; Device Slipped; Failure to Align

  ACCORDING TO THE REPORTER, DURING AN OPEN ANTERIOR RESECTION, WHEN PERFORMING RECTOSIGMOIDAL ANASTOMOSIS, WHILE CLOSING THE STAPLER, THE GREEN BAR WAS NOT VISIBLE, SO THE SURGEON USED EXCESSIVE FORCE TO CLOSE IT. AFTERWARDS, THE USER FOUND THAT THE PROXIMAL END OF THE ANVIL RIPPED THE SIGMOID. THE ANVIL WAS TILTED BEFORE FIRING, AND IT WAS STILL ATTACHED TO THE INTEGRATED TROCAR. IT WAS REPORTED THAT THE INCISION WAS EXTENDED BY MORE THAN 1 INCH DUE TO THE PRODUCT PROBLEM, AND THE PATIENT UNDERWENT CHEMOTHERAPY OR RADIATION TREATMENTS. THE SIGMOID WAS FIXED WITH HAND SEWING.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 18798297 ↗
• MalfunctionFeb 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, THE STAPLER DID NOT FIRE. THE USER EXCHANGED FOR ANOTHER CLAMP FROM THE SAME MANUFACTURER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700004 ↗
• MalfunctionFeb 12, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLORECTAL SURGERY, WHEN SURGEON TRIGGERED THE STAPLING PROCEDURE, THERE WERE ONLY STAPLES ON THE RECTAL SIDE OF THE ANASTOMOSE. THE ANASTOMOSIS HAD TO BE COMPLETELY REDONE, WITH A LARGER COLORECTAL INCISION. ANOTHER STAPLER FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown

  MAUDE report 18692431 ↗
• MalfunctionJan 16, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DEEP ENDOMETRIOSIS PROCEDURE, THE ANVIL OF THE DEVICE DID NOT TILT AFTER STAPLING THE ANASTOMOSIS. IT WAS NOTED THAT THE ANVIL WAS BENT. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18522806 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO LAPAROSCOPIC RECTOSIGMOIDECTOMY, THE POSTERIOR PORTION OF THE ANASTOMOSIS HAD A BLEEDING, WHICH WAS RESOLVED VIA MANUAL SUTURING AND A GAS INSTALLATION TEST WAS PERFORMED THROUGH THE ANUS WHICH CONFIRMED THAT THERE WAS NO LEAK. ON THE 3RD POST-OPERATIVE DAY, THERE WAS WOUND DEHISCENCE IN THE OPENING OF THE ANASTOMOSIS AT THE INTERSECTION OF THE STAPLE LINE, AN EXPLORATORY LAPAROTOMY, AND A COLOSTOMY WAS MADE IN THE DESCENDING COLON LOOP. THEN 4 DAYS AFTER THE INITIAL LAPAROTOMY, THE PATIENT HAD FEVER, TACHYCARDIA, AND SIGNIFICANT ABDOMINAL PAIN. ANOTHER EXPLORATORY LAPAROTOMY, WAS THEN PERFORMED, WHICH SHOWED EVIDENCE OF NECROSIS OF THE EFFERENT SEGMENT OF THE COLON OF THE LOOP COLOSTOMY, RESECTION OF THE NECROTIC SEGMENT WAS THEN PERFORMED AND THE COLORECTAL ANASTOMOSIS WAS UNDONE AND TERMINAL COLOSTOMY WAS PERFORMED AND THE RECTAL STUMP CLOSURE WAS ALSO PERFORMED. THE PATIENT'S CONDITION PROGRESSED TO DAILY FEVER AND LEUKOCYTOSIS. A CONTROL TOTAL ABDOMEN WAS PERFORMED, TOMOGRAPHY WAS PERFORMED WITH MULTIPLE INTRA-ABDOMINAL COLLECTIONS AND A NEW EXPLORATORY LAPAROTOMY WAS INDICATED TO HEAL THE CAVITY. THE PATIENT'S CONDITION PROGRESSED TO

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count; Necrosis; Tachycardia; Tissue Breakdown; Unintended Radiation Exposure; Wound Dehiscence

  MAUDE report 18470916 ↗
• MalfunctionSep 28, 2023Failure to Align; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Align; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RECTOSIGMOIDECTOMY PROCEDURE, WHEN RESECTING THE LESION IN THE RECTUM USING THE DEVICE, AFTER THE STAPLER WAS INTRODUCED IN THE ANUS, THE ANVIL TILTED BEFORE CLAMPING AND AFTER THE STAPLER WAS REMOVED, IT REMAINED IN THE PATIENT'S RECTUM, REQUIRING MANUAL REMOVAL OF THE ANVIL. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS INCREASED BY 40 MINUTES DUE TO THE DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836919 ↗
• MalfunctionSep 6, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A FAILURE IN OPENING THE WARHEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690803 ↗