EEA EEAXL21Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884523005578), received between Dec 8, 2017 and Jul 31, 2025 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ESOPHAGEAL COLLIS USING A CIRCULAR STAPLER IN THE ABDOMEN, THE SMALL GREEN CARTRIDGE RING FELL OUT OF THE END OF THE STAPLER, RENDERING THE INSTRUMENT UNUSABLE WITH PIECES FALLING INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED BY THE SURGEON WITHOUT THE NEED FOR X-RAY IMAGING. THE DEVICE WAS REPLACED, AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678222 ↗
• MalfunctionAug 3, 2023Difficult to Remove; Misfire; Failure to Form Staple; Noise, Audible; Difficult to Remove; Misfire; Failure to Form Staple; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE CREATING THE GASTROJEJUNOSTOMY, A CRACKING SOUND WAS HEARD WHEN THE DEVICE WAS FULLY SQUEEZED. UPON OPENING THE DEVICE, THE SURGEON OBSERVED THAT THE DEVICE PARTIALLY FIRED, THE STAPLES WERE ENTIRELY OPEN, AND THE DONUT WAS INCOMPLETE. IT WAS NOTED THAT THE DEVICE WAS APPLIED OVER A PREVIOUS STAPLE LINE. THE SURGEON HAD CUT THE TISSUE AROUND THE ANVIL PORTION IN ORDER TO REMOVE THE DEVICE. A NEW SET OF DEVICES WAS USED TO RE-STAPLE THE TISSUE. A LEAK TEST WAS THEN PERFORMED ON NEW GASTROJEJUNOSTOMY ANASTOMOSIS, AND IT PASSED. THIS LED TO ROUGHLY 25 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 17455015 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE COMPONENT DISENGAGED. THERE WAS NO COMPONENT THAT FELL INTO THE PATIENT'S CAVITY. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086142 ↗
• MalfunctionNov 6, 2020Break; Break

  ACCORDING TO THE REPORTER, AT THE END OF THE ANASTOMOSIS IN A GASTRIC BYPASS PROCEDURE, THE ANVIL OF THE DEVICE BROKE. THE PLASTIC WHITE SPIKE APPARENTLY BROKE AND BECAME LODGED IN THE LEGS OF THE ANVIL. SURGEON USED OPENED NEW DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10803556 ↗
• InjuryDec 2, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, AT THE TIME OF GASTRO-JEJUNO ANASTOMOSIS DURING LAPAROSCOPIC GASTRIC BYPASS, THE FIRST DEVICE DID NOT CUT THE SUTURE AND PART OF THE SUTURE WAS LEFT IN ANASTOMOSIS STAPLE LINE. ON THE SECOND DEVICE, THE SUTURE DID NOT CUT COMPLETELY. IT WAS STATED THAT THERE WAS AN UNANTICIPATED LOSS OF TISSUE. THE SURGEON DECIDED TO TRANSECT AND REDO THE ANASTOMOSIS.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9397009 ↗
• MalfunctionOct 17, 2019Difficult to Remove; Noise, Audible; Difficult to Remove; Noise, Audible

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON ANASTOMOSIS DURING A LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE NEVER MADE AN AUDIBLE CLICK AFTER THE 2 TURNS COUNTERCLOCKWISE. IT WAS ALSO REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE CAVITY, HOWEVER, THE SURGEON HAD TO SLOWLY PULLED IT OUT AND THE DEVICE WAS REMOVED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203191 ↗
• InjurySep 3, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN FIRING DURING GASTROJEJUNOSTOMY ON A LAPAROSCOPIC GASTRIC BYPASS WITH ROUX-EN-Y PROCEDURE, THE DEVICE FAILED TO FULLY FIRE. THE SURGEON HAD TO CHANGE THE SURGICAL PROCEDURE AND HAND SEWED THE ANASTOMOSIS TO COMPLETE THE DIGESTIVE TRACT. THIS RESULTED TO ADDITIONAL INCISION TO THE BOWEL AND SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8954558 ↗
• MalfunctionMar 18, 2019Misfire; Failure to Cut; Mechanics Altered; Misfire; Failure to Cut; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE SUTURE FROM THE DEVICE FAILED TO CUT AND CAME OUT WITH THE INSTRUMENT AFTER FIRING AND IT WAS STUCK TO THE DONUTS THAT LOOKED A LITTLE THIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430137 ↗
• MalfunctionAug 31, 2018Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS BROKEN AND WOULD NOT LOCK INTO ANVIL. PIECE (FLANGE) WAS MISSING ON WHITE TROCAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7837941 ↗
• MalfunctionMay 15, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE PARTIALLY FIRED. THE STAPLER DID NOT CUT ALL THE WAY AROUND AND LEFT A PIECE OF THE ANASTOMOSIS INSIDE THE STOMACH. THE CASE WAS CONTINUED AND COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7514776 ↗
• MalfunctionFeb 19, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS REVISION SURGERY, AFTER THE SURGEON FIRED THE STAPLER TO COMPLETE THE ANASTAMOSIS, HE WAS UNABLE TO PULL IT OUT AFTER IT TILTED. THE SURGEON ENDED UP USING A GASTRO SCOPE IN ORDER TO GUIDE OUT THE STAPLER VISUALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280031 ↗
• MalfunctionDec 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ACCORDING TO THE REPORTER: DURING A ROUX-EN-Y GASTRIC BYPASS PROCEDURE. FIRED EEA WITH ORVIL. THE RETRIEVAL SUTURE DID NOT CUT. SURGEON HAD TO USE SCISSORS TO CUT IT. THERE WAS NO RE-OPERATION, ETC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500 CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED.*** ADDITIONAL INFORMATION RECEIVED VIA EMAIL *** CAN YOU CONFIRM THAT PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION. YES, I SENT A E-MAIL YESTERDAY ASKING FOR A RETURN PACKAGE TO BE SENT TO THE HOSPITAL WHAT ARE THE UDIS OF THE DEVICES? PLEASE SEE ATTACHED PICS OF THE PRODUCT STICKERS. WHAT WAS THE DATE OF THE PROCEDURE? (B)(6) 2016. WHAT IS THE PATIENT AGE, WEIGHT, GENDER, RACE, ETHNICITY, OR PATIENT IDENTIFIER (I.E. INITIALS OR ID NUMBER, NOT THE FULL NAME OF THE PATIENT)? NOT AVAILABLE. WHAT IS THE LAST KNOWN PATIENT STATUS? PATIENT WAS FINE, NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142492 ↗
• MalfunctionDec 8, 2017Bent; Positioning Problem; Bent; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. THE DEVICE WAS USED AND COULD NOT BE MATED TO THE INSTRUMENT DUE TO THE CENTER ROD PRONGS BEING BENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7100378 ↗