EEA EEA21Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884523004663), received between Aug 24, 2017 and Mar 18, 2025 — classified as 17 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (19 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Device Slipped; Failure to Form Staple; Detachment of Device or Device Component; Device Slipped; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF ESOPHAGEAL CANCER PROCEDURE, WHEN THE STAPLER WAS ACTIVATED, THE DEVICE COULD NOT BE COMPLETELY CLOSED AND THE STAPLE BURST OUT. THE STAPLE FELL OFF AND FELL INTO THE CHEST CAVITY. THE SURGEON THEN REMOVED THE LOST STAPLES ONE BY ONE USING AN ASPIRATOR FOR SUCTION. TO COMPLETE THE CASE, A NEW DEVICE WAS USED. THIS RESULTED IN PROLONGED SURGERY TIME OF LESS THAN 30 MINUTES AND INCREASED RISK OF INFECTION.

  Patient problems: Tissue Breakdown

  MAUDE report 21636684 ↗
• MalfunctionFeb 24, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY OF ESOPHAGOGASTRIC JUNCTION CANCER, THE EGIAUSTND DEVICE COULD NOT FIRE THE RELOAD WHEN THE DUODENUM WAS DETACHED. THE ISSUE WAS RESOLVED BY REPLACING THE HANDLE, ALLOWING THE FIRING TO BE COMPLETED. ADDITIONALLY, WHEN USING THE EEA21 STAPLER TO ANASTOMOSE THE ESOPHAGUS AND JEJUNUM, THE STAPLES DID NOT FORM A GOOD B SHAPE, RESULTING IN THE STAPLES BURSTING OUT AND CAUSING BLEEDING. IT WAS ALSO NOTED THAT THE DONUTS WERE INCOMPLETE. THIS NECESSITATED MANUAL ANASTOMOSIS TO COMPLETE THE PROCEDURE.

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

  MAUDE report 21447078 ↗
• MalfunctionFeb 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE STAPLER, THE GREEN RING ON THE FRONT OF THE STAPLER FELL OFF INTO THE PATIENT'S CAVITY. IT WAS NOTED THAT THE COMPONENT WAS RETRIEVED. THE DEVICE WAS REPLACED WITH A NEW PRODUCT TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344226 ↗
• MalfunctionFeb 7, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y PROCEDURE, WHEN PERFORMING A RADICAL RESECTION OF ESOPHAGOGASTRIC JUNCTION CANCER, THE JEJUNUM AND ESOPHAGUS WERE ANASTOMOSED, THE STAPLES WERE NOT PROPERLY FORMED, THE ANASTOMOTIC SPECIMEN DID NOT HAVE A COMPLETE "DONUT", AND THE STAPLE LINE WAS INCOMPLETE, AND STAPLES BURST OUT. MANUAL SUTURING WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 21334389 ↗
• MalfunctionJan 7, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RADICAL RESECTION OF CARDIAC CANCER, WHILE ON DETACHMENT OF THE DUODENUM THE HANDLE COMBINED WITH THE RELOAD. HOWEVER, COULD NOT BE ACTIVATED. AFTER REPLACING THE RELOAD, THE SAME ERROR OCCURRED. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. A NEW HANDLE WAS REPLACED TO COMPLETE THE ACTIVATION. DURING THE ANASTOMOSIS OF THE ESOPHAGUS AND JEJUNUM, THE STAPLE DID NOT FORM A GOOD B-SHAPE AFTER CIRCULAR STAPLER ACTIVATION AND BLEEDING OCCURRED. AT THE SAME TIME, THERE WAS NO COMPLETE CIRCULAR SPECIMEN TISSUE AFTER THE STAPLE ANVIL WAS REMOVED. IT WAS SUTURED MANUALLY USING CURB STITCHING TO RESOLVE THE ISSUE.

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

  MAUDE report 21093734 ↗
• MalfunctionNov 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL RESECTION OF ESOPHAGOGASTRIC JUNCTION CANCER, A STAPLER WAS USED WHEN THE DUODENUM WAS DETACHED. THE SUTURE LINE WAS INCOMPLETE, THE STAPLES DID NOT FORM INTO A GOOD B-SHAPE, BLEEDING OCCURRED, AND IT WAS FINALLY SUTURED MANUALLY. DURING THE R-Y ANASTOMOSIS OF THE ESOPHAGUS AND JEJUNUM, THE EEA21 COULD NOT BE FIRED NORMALLY. THE OPERATION WAS COMPLETED AFTER REPLACING IT WITH A NEW HANDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20801461 ↗
• MalfunctionOct 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490090 ↗
• MalfunctionOct 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE PATIENT HAD T3B (TUMOR HAS SPREAD TO THE SEMINAL VESICLES) GASTRIC CANCER AND UNDERWENT RADICAL SURGERY FOR GASTRIC CANCER UNDER OPEN SURGERY. WHEN DETACHING THE DUODENUM, THE LINEAR OPEN STAPLER WAS USED, THE STAPLES BURST OUT, THE STAPLES WERE NOT FORMED WELL, AND THE ANASTOMOSIS WAS BLEEDING. THE STAPLE LINE OPENED UP. FINALLY, IT WAS SUTURED MANUALLY. WHEN THE SMALL INTESTINE AND ESOPHAGUS WERE SUBSEQUENTLY ANASTOMOSED, THE OPEN CIRCULAR STAPLER WAS USED, BUT IT COULD NOT BE FIRED. AFTER REPLACING IT WITH A NEW CIRCULAR STAPLER, THE OPERATION WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 20396909 ↗
• MalfunctionOct 3, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTROJEJUNAL PROCEDURE, WHEN THE STOMACH WAS CONNECTED TO THE JEJUNUM, THE DEVICE PARTIALLY FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 20359791 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COMBINED THORACIC AND ABDOMINAL ESOPHAGEAL CANCER SURGERY, WHEN THE CIRCULATING NURSE OPENED THE PACKAGE, THE BUCKLE OF THE ANVIL HEAD WAS NOT TIGHTENED AND FELL OFF, CAUSING CONTAMINATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197536 ↗
• MalfunctionJun 4, 2024Expulsion; Expulsion

  ACCORDING TO THE REPORTER, IN A TOTAL GASTRECTOMY WITH ESOPHAGOJEJUNOSTOMY, THE SCRUB NURSE FOUND THAT THE STAPLES OF THE NEWLY OPENED CIRCULAR STAPLER FELL OFF AFTER OPENING THE PACKAGE. THE DEVICE WAS REPLACED WITH ANOTHER FOR ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460572 ↗
• MalfunctionMay 23, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION. TO RESOLVE THE ISSUE, ANOTHER RE-STAPLING AND RESECTION WERE PERFORMED USING A NEW CIRCULAR STAPLER.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19385732 ↗
• MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RADICAL ESOPHAGECTOMY, DURING ANASTOMOSIS OF THE ESOPHAGUS, THE CENTER ROD DEVIATED. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754323 ↗
• MalfunctionDec 15, 2023Difficult to Remove; Misfire; Failure to Form Staple; Misassembly by Users; Difficult to Remove; Misfire; Failure to Form Staple; Misassembly by Users

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL SURGERY OF ESOPHAGEAL CANCER, AT THE TIME OF ESOPHAGEAL ANASTOMOSIS, THERE WAS A POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE. SOME OF THE STAPLES WERE NOT FORMED, AND THE LEGS OF THE STAPLES WERE STRAIGHT AND NOT BENT. AN IMPROPERLY MATCHED INSTRUMENT AND ANVIL COMBINATION WAS USED, AND THE DONUTS WERE INCOMPLETE. MOREOVER, THE ANVIL COULD NOT BE TILTED AFTER FIRING. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. TO RESOLVE THE ISSUE, THE SURGEON ADDED ANOTHER CIRCLE OF SUTURING FOR ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 18339825 ↗
• MalfunctionNov 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVE, DISTAL GASTRECTOMY, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18122914 ↗
• MalfunctionJun 21, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING DISTAL GASTRECTOMY, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL WAS CLOSED AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW BUT THE CIRCULAR STAPLER WOULD NOT FIRE. ANOTHER DEVICE 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 17177211 ↗
• MalfunctionJun 21, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING SUBTOTAL GASTRECTOMY, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL WAS CLOSED AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW BUT THE CIRCULAR STAPLER WOULD NOT FIRE. ANOTHER DEVICE 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 17177193 ↗
• MalfunctionJan 3, 2023Device Slipped; Failure to Fire; Device Slipped; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL PROCEDURE, WHEN THE SURGEON WANTED TO CLOSE THE DEVICE, THE JAWS DID NOT CLOSE ON THE TISSUE. WHEN THE HAND OF THE SURGEON RELAXED AND OPENED, THE JAWS WERE STILL OPEN AND WERE NOT ABLE TO FIRE; THEREFORE, THE TISSUE COULD NOT BE STAPLED. THE GREEN BUTTON DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16086798 ↗
• InjuryDec 28, 2022Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL SURGERY FOR ESOPHAGEAL CANCER, ESOPHAGOGASTRIC ANASTOMOSIS USING THE DEVICE, THERE WAS A POOR STAPLE FORMATION AFTER ANASTOMOSIS AND ADDED SEAM FOR HEMOSTASIS. THE DONUTS WERE COMPLETE. THE SURGEON OVER SEWED TO FIXED THE STAPLE LINE AND THE ANVIL COULD NOT BE TITLED AFTER FIRING.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16063319 ↗
• InjuryDec 27, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, WHILE ON ANASTOMOSIS OF THE ESOPHAGUS-SMALL INTESTINE, THERE WAS POOR STAPLE FORMATION. THE SURGERY WAS COMPLETED AFTER BEING SEWN WITH SUTURE.

  Patient problems: Failure to Anastomose

  MAUDE report 16052892 ↗
• InjuryDec 27, 2022Detachment 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 OPEN NECK ANASTOMOSIS OF ESOPHAGUS AND TUBE AND STOMACH, THE ANVIL FELL OFF. WHEN FIRING OFF THE ESOPHAGUS, THE STAPLER CUT THE TISSUE BUT DID NOT STAPLE AND ESOPHAGUS TISSUE HAD DAMAGE. THE EVENT LED TO UNANTICIPATED TISSUE LOSS AND SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE TO MANUALLY PERFORM ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16050884 ↗
• InjurySep 20, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL GASTRECTOMY, THE DEVICE WAS USED TO ANASTOMOSE THE DIGESTIVE TRACT AND THE OPERATION WAS PERFORMED ACCORDING TO THE STANDARD. THE STAPLER DID NOT FIRE AND IT CAUSED DAMAGE TO THE GASTROINTESTINAL MUCOSA OF THE PATIENT, WHICH REQUIRED RE-ANASTOMOSIS AND PROLONGED THE SURGERY TIME. A NEW DEVICE DEVICE WAS USED TO RESOLVED THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15457068 ↗
• InjurySep 15, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF ESOPHAGEAL CANCER, WHEN THE NEW DEVICE WAS USED FOR ANASTOMOSIS OF THE ESOPHAGUS-JEJUNUM, IT WAS OBSERVED THAT THE STAPLES WERE POORLY FORMED. THE STAPLE LINE WAS FIXED BY SUBSEQUENTLY OVER SEWING THE ANASTOMOSIS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15429047 ↗
• MalfunctionJul 22, 2022Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL CANCER RADICAL SURGERY, WHILE ANASTOMOSING THE REMNANT STOMACH AND ESOPHAGUS, THE DEVICE PARTIALLY FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088042 ↗
• MalfunctionJul 20, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL CANCER RADICAL SURGERY, WHILE AT THE ANASTOMOSIS OF REMNANT STOMACH AND ESOPHAGUS, THE DEVICE PARTIALLY FIRED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066126 ↗