EEA EEA2835Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884523005547), received between Oct 25, 2016 and May 7, 2026 — classified as 1 death, 37 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (22 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION OF THE RECTUM, DURING RECTAL TRANSECTION AND RECTAL ANASTOMOSIS, POOR STAPLE FORMATION WAS OBSERVED FROM THE LINEAR STAPLER. MEANWHILE, A PARTIAL STAPLE FORMATION FAILURE WAS OBSERVED ON THE CIRCULAR STAPLER. THE STAPLE LINE WAS RESECTED AND RE-STAPLED, AND THE DEVICES WERE REPLACED WITH A NEW RELOAD AND A CIRCULAR STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 25117045 ↗
• MalfunctionApr 14, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SIGMOID COLECTOMY WITH ROBOTIC SUPPORT, AFTER CONNECTING THE ANVIL TO THE STAPLER AND RELEASING THE SAFETY LEVER, THE HANDLE COULD NOT BE SQUEEZED. THE BLACK RETURN KNOB WAS LOOSENED, AND THE ANVIL AND STAPLER WERE RELEASED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW STAPLER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. THE SURGERY WAS EXTENDED BY 20 MINUTES DUE TO THE DEVICE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873667 ↗
• MalfunctionNov 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SIGMOID COLECTOMY, WHILE RECONSTRUCTING THE DIGESTIVE TRACT, THERE WAS POOR STAPLE FORMATION. THE STAPLE LINE WAS OVER SEWED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 23570809 ↗
• MalfunctionNov 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, DURING RECONSTRUCTING THE DIGESTIVE TRACT, THE STAPLES DID NOT CLOSE PROPERLY. THE SURGEON OVER-SEWED THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 23569786 ↗
• InjuryAug 13, 2025Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY, WHEN THE SURGEON FIRED THE DEVICE FOR AN END TO END ANASTOMOSIS, NO STAPLES DEPLOYED. INTESTINAL FLUID AND FECES OVERFLOWED INTO THE ABDOMINAL CAVITY. THE PATIENT'S ABDOMINAL CAVITY HAD TO BE THOROUGHLY WASHED AND THE RECTUM WAS SUTURED TO MAKE A COLOSTOMY. THE PATIENT HAD FEVER AND PARTIAL INTESTINAL OBSTRUCTION.

  Patient problems: Failure to Anastomose; Fever; Obstruction/Occlusion

  MAUDE report 22801392 ↗
• MalfunctionNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE DEVICE BROKE AND DISENGAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774853 ↗
• MalfunctionOct 29, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF RECTAL CANCER, THE DEVICE WAS TURNED ON THE SAFETY, ROTATED THE KNOB AT THE TAIL OF THE STAPLER UNTIL A GREEN STRAIGHT LINE WAS DISPLAYED, AND PRESSED THE HANDLE SWITCH, BUT THE STAPLER WAS UNABLE TO BE FIRED. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20562704 ↗
• MalfunctionAug 9, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE COLECTOMY, THERE WAS VERTICALIZATION PROBLEM OF THE HEAD OF THE ANVIL. THE SURGEON RETIRED THE DEVICE AS THE ANVIL HAS NOT TOTALLY TILTED, THE ANASTOMOSIS TORE AND THE SURGEON HAD TO REDO THE ANASTOMOSIS USING ANOTHER CIRCULAR STAPLER. IT WAS ALSO NOTED THAT THE ANVIL WAS BENT. THE SURGICAL TIME WAS EXTENDED FOR 20 MINUTES AS A RESULT.

  Patient problems: Failure to Anastomose

  MAUDE report 19951043 ↗
• MalfunctionAug 8, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLOSTOMY REVERSAL PROCEDURE, AFTER FIRING IN THE ANASTOMOSIS OF THE COLON, THE DEVICE WAS STUCK WHEN TRYING TO REMOVE IT FROM THE PATIENT'S CAVITY. THE STAPLER WAS ABLE TO BE REMOVED FIRST, BUT THE ANVIL STAYED IN THE PATIENT. THE PROCEDURE WAS EXTENDED FOR 30 MINUTES, AND THE ANVIL WAS EVENTUALLY ABLE TO BE REMOVED BY A LAPAROSCOPIC INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944334 ↗
• MalfunctionDec 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE BODY AND DLU UNIT COULD NOT BE ASSEMBLED. A NEW DEVICE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358326 ↗
• MalfunctionNov 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, OPERATOR SAID THAT BODY AND LOADING UNIT COULD NOT BE ASSEMBLED. A NEW ADDITIONAL LOADING UNIT WAS LOADED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213089 ↗
• MalfunctionOct 23, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT HEMICOLECTOMY, THE STAPLER WAS UNABLE TO CONNECT WITH THE ANVIL. THE USER OPENED A NEW STAPLER AND THE DEVICE CONNECTED PERFECTLY. THE FIRING, ANVIL TILTED AND STAPLE LINE WERE ALL CORRECT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986306 ↗
• MalfunctionSep 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CIRCULAR STAPLER DID NOT CUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746873 ↗
• MalfunctionAug 30, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RECTAL CANCER PROCEDURE, THE DEVICE PARTIALLY FIRED. THE DEVICE WAS REPLACED WITH A NEW CIRCULAR STAPLER AND SUCCESSFULLY COMPLETED THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652306 ↗
• MalfunctionJul 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, COLECTOMY PROCEDURE, THERE WAS A DIFFICULTY INTRODUCING THE UNCLE INTO THE CIRCULAR STAPLER. THE DEVICE WAS CHANGE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350254 ↗
• MalfunctionJun 30, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY RECTAL SURGERY, WHEN THE LOCK WAS APPLIED, DURING THE USE OF THE FIRST STAPLER, IT DID NOT FIRE. A SECOND STAPLER WAS USED BUT SAME ISSUE OCCURRED. ALL ANVILS HAVE BEEN REPLACED. A THIRD CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243804 ↗
• MalfunctionJun 7, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RECTAL CANCER SURGERY, DURING RECTAL ANASTOMOSIS, THE DEVICE DID NOT FIRE. THE DEVICE DID NOT WORK AT ALL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080961 ↗
• InjuryJun 5, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE SEEMED TO FUNCTION PROPERLY BUT THE PATIENT CAME BACK WITH A LEAK AT THE ANA STOMOSIS. THE PATIENT NEEDED TO HAVE THE ANASTOMOSIS REDONE.

  Patient problems: Failure to Anastomose

  MAUDE report 17061526 ↗
• MalfunctionApr 24, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER WAS UNABLE TO LOAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16799577 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL CANCER RESECTION, WHEN USING THE STAPLER TO DETACH THE RECTUM, THE ANVIL CAP FELL OFF. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16677813 ↗
• MalfunctionApr 4, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMI COLON SURGERY, REBUILD DIGESTIVE TRACT, THE DEVICE PARTIALLY FIRED. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16674687 ↗
• MalfunctionMar 10, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING AN OPEN HARTMAN RECONNECTION, ON THE STAPLING PHASE, THE SURGEON REPORTED DIFFICULTY TO CONNECT THE ANVIL TO THE TROCAR OF THE CIRCULAR STAPLER. AT THE END, THE DOCTOR WAS ABLE TO CONNECT THE ANVIL WITH THE STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524151 ↗
• MalfunctionDec 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTROINTESTINAL PROCEDURE, DURING DIGESTIVE TRACT RECONSTRUCTION, A COMPONENT OF THE DEVICE DISENGAGED. ANOTHER KIND OF CIRCULAR STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056791 ↗
• InjuryOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANVIL REMAINED IN THE PATIENT AFTER STAPLING AND WAS NOT ON THE CLAMP. THE SURGEON HAD TO FIND THE ANVIL IN THE PATIENT WHICH LED TO EXTENSION OF THE SURGERY AND EXTENDED HOSPITALIZATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15663121 ↗
• InjuryOct 14, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY, AFTER FIRING, POOR B-STAPLE FORMATION WAS OBSERVED. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15608129 ↗