EEA EEAXL28Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 10884523006131), received between Mar 23, 2017 and Jan 14, 2026 — classified as 52 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (25 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.

• MalfunctionJan 14, 2026Failure to Form Staple; Failure to Cut; Firing Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING PROCEDURE, THE STAPLER HANDLE DID NOT FULLY CLOSE AND THERE WAS SIGNIFICANT RESISTANCE DURING FIRING, RESULTING IN AN INCOMPLETE STAPLE LINE WITH STAPLES THAT WERE PARTIALLY FIRED AND NOT CUT. MOST OF THE STAPLES WERE REMOVED WITH THE STAPLER, BUT APPROXIMATELY FOUR STAPLES REMAINED EMBEDDED AND ONLY PARTIALLY CLOSED IN THE RECTAL STUMP, NECESSITATING THEIR REMOVAL. THE ANVIL WAS THEN REMOVED AND REPLACED WITH A NEW ONE, AND THE BOTTOM OF THE STAPLER WAS REINSERTED, ALLOWING THE POST TO BE BROUGHT THROUGH THE EXISTING HOLE FROM THE FIRST ATTEMPT. THE PROCEDURE WAS EXTENDED BY ONE HOUR DUE TO FIRING ISSUES WITH THE STAPLER. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING.

  Patient problems: Failure to Anastomose

  MAUDE report 24070370 ↗
• InjuryOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE ANVIL DETACHED FROM THE END OF THE CLAMP, REMAINING IN THE PATIENT'S COLON. A MINI-LAPAROTOMY WAS REQUIRED TO RECOVER THE DETACHED PART AND THE SURGEON CONFIRMED FOLLOWING THE LOOSENING PROCEDURE UNTIL THE SECURITY CLICK.

  Patient problems: Laceration(s)

  MAUDE report 23353909 ↗
• InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POSTOPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES, AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POSTOPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PIN POINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23334107 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POST-OPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES, AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POST-OPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PIN POINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23328192 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POST-OPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POST-OPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PIN POINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23328127 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POSTOPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES, AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POSTOPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PINPOINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23325693 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POSTOPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES, AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POSTOPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PIN POINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23325646 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SHORT PERIOD OF TIME, THE PATIENT WHO UNDERWENT ESOPHAGEAL CANCER RESECTION EXPERIENCED POSTOPERATIVE ANASTOMOTIC LEAKAGE AFTER USE OF A CIRCULAR STAPLER. NO ABNORMALITIES WERE OBSERVED DURING THE PROCEDURES, AND BOTH CIRCULAR AND LINEAR STAPLING WERE PERFORMED AS EXPECTED. LEAK TESTS WERE CONDUCTED AND WERE NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, WITH NO ANASTOMOSIS LEAKING CONTENT NOTED INTRAOPERATIVELY. TYPICALLY, ABOUT TEN DAYS POSTOPERATIVELY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH A PINPOINT LEAK AT THE CIRCULAR ANASTOMOSIS. VACUUM THERAPY WAS PROVIDED AS TREATMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 23325202 ↗
• MalfunctionJul 15, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING AN OPEN ANTERIOR RESECTION, DURING ANASTOMOSIS OF THE COLON THE STAPLE LINE WAS BLEEDING AFTER FIRING. A NEW CIRCULAR STAPLER OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22508632 ↗
• MalfunctionJan 20, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO REMOVE FROM CAVITY. IT WAS NOTED THAT THE DEVICE WAS REMOVED AND ANVIL DISCONNECTED FROM TROCAR TIP. THE PHYSICIAN ATTEMPTED TO GRAB VIA RECTUM AND WAS UNABLE TO RETRIEVE RESULTING IN PHYSICIAN HAVING TO CUT THE ANVIL OUT AND RE-DO THE ANASTOMOSIS. RESECTION AND RE-STAPLING WERE DONE TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR 30 TO 45 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21191764 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF DIVISION OF COLON APPROXIMATION OF RECTAL STUMP. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AIR-CONTAINING COLLECTION, ABSCESS, LABS ABNORMAL FOR CREATININE; WBC, PURULENT FLUID, FISTULA, FEVER, ELECTROLYTE IMBALANCE, ANASTOMOSIS LEAK. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, HOSPITALIZATION, INTERVENTIONAL RADIOLOGY PROCEDURE, BIOPSY/ASPIRATION OF ABDOMEN DRAINAGE, ANTIBIOTICS, POTASSIUM SUPPLEMENTATION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electrolyte Imbalance; Fever; Fistula; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 19914367 ↗
• MalfunctionJul 19, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, THE SURGEON COULD NOT ENGAGE THE ANVIL INTO THE FORCEPS FOR ANASTOMOSIS. TO RESOLVE THE ISSUE, A NEW DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781843 ↗
• MalfunctionJun 21, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HIGH RECTAL CANCER RADICAL PROCEDURE, WHEN THE CIRCULAR STAPLER WAS USED TO COMPLETE THE INTESTINAL RECONSTRUCTION, THE HANDLE BODY INSERTED THROUGH THE ANUS COULD NOT PASS THROUGH THE INTESTINAL TRACT SMOOTHLY. THE INNERMOST MUCOSAL LAYER HAD INTUSSUSCEPTION. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589912 ↗
• MalfunctionApr 23, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS ABLE TO CUT THE TISSUE HOWEVER, NO STAPLES WERE DEPLOYED. ANOTHER DEVICE WAS USED TO REDO THE ANASTOMOSIS CAUSING LOSS OF TIME.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19166411 ↗
• MalfunctionApr 10, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A COLECTOMY PROCEDURE, AT THE TIME OF ANASTOMOSIS, THE DEVICE CUT THE TISSUE. HOWEVER, IT DID NOT STAPLE THE TISSUE. THE SURGEON REPEATED THE ANASTOMOSIS WITH A NEW DEVICE TO RESOLVE THE ISSUE. THIS LED TO A LOSS OF TIME.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19081380 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible; Detachment of Device or Device Component; Insufficient Device Problem Information; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A OPEN COLOSOTOMY REVERSAL, WHEN CREATING THE ANASTOMOSIS OF THE COLON, THE SURGEON SQUEEZED THE DEVICE ONCE TO FIRE THE DEVICE. AFTERWARDS, WHEN THE SURGEON DECIDED TO DO A SECOND SQUEEZE, 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 BY HAND. IT WAS ALSO REPORTED THAT THE ANASTOMOSIS HAD A LEAK.

  Patient problems: Failure to Anastomose; Insufficient Information; Tissue Breakdown

  MAUDE report 19033273 ↗
• MalfunctionApr 2, 2024Loss of or Failure to Bond; Human-Device Interface Problem; Loss of or Failure to Bond; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SMALL SPIKE FROM THE 28-MM CIRCULAR STAPLER DID NOT SIT WELL ON THE ANVIL, IT WAS LOOSE. ANOTHER STAPLER OPENED, USED A DIFFERENT TECHNIQUE THAT DID NOT REQUIRE THE SPIKE AND PERFORMED THE ANASTOMOSIS WITH THE SECOND DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021768 ↗
• MalfunctionApr 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SMALL SPIKE FROM THE 28-MM CIRCULAR STAPLER DID NOT SIT WELL ON THE ANVIL. ANOTHER STAPLER OPENED, AND THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019376 ↗
• MalfunctionAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC CLOSURE OF A COLOSTOMY, THE STAPLES FIRED DID NOT PROPERLY STAY IN THE INTENDED STAPLE LINE, BECOMING LOOSE INSIDE THE PATIENT. THE SURGEON HAD TO DISSECT THE AFFECTED TISSUE AND USE A DIFFERENT STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 17650258 ↗
• MalfunctionJul 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, PRIOR TO A RIGHT HEMICOLECTOMY, THE DEVICE WAS NOT PROPERLY COMBINED AND COULD NOT BE USED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375467 ↗
• MalfunctionMar 18, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE WHITE ANVIL SPIKE BROKE WHILE IT WAS BEING PREPARED ON THE BACK TABLE. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569485 ↗
• InjuryJan 26, 2023Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RESECTION, WHILE ON ANASTOMOSIS OF RECTUM STUMP TO THE COLON, THE DEVICE PARTIALLY FIRED, HAD INCOMPLETE STAPLE LINE, AND THE ANVIL COULD NOT BE TILTED AFTER FIRING. MANUAL OVER SEWING WAS DONE TO TIE THE ANASTOMOTIC SITE. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE TO ALLOW MORE TIME TO SUTURE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16245826 ↗
• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ENDOMETRIOSIS PROCEDURE, THE ANVIL AND THE YELLOW ATTACHMENT WERE NOT CONNECTED TO THE STAPLER. DUE TO THIS, THE ANVIL DROPPED TO THE FLOOR AND BECAME NON-STERILE, MAKING IT IMPOSSIBLE TO USE IN PATIENT. A NEW STAPLER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859199 ↗
• MalfunctionNov 7, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15744505 ↗
• MalfunctionSep 14, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, AFTER SURGERY, THE STAPLES HAD POOR FORMATION. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420864 ↗