EEA EEAXL2135Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10884523005585), received between Apr 19, 2017 and Apr 22, 2025 — classified as 14 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE CIRCULAR STAPLER, THERE WERE SEVERAL ISSUES. THE PROCEDURE EXPERIENCED EXTENDED SURGICAL TIME DUE TO STAPLE LINE ISSUES AND STAPLE LINE BLEEDING. ADDITIONALLY, THE DONUT WAS INCOMPLETE OR MISSING AFTER THE FIRING OF THE STAPLER. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO ADDRESS THE INCOMPLETE DONUT ISSUE. THE PRODUCT WAS SUBSEQUENTLY EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 21883312 ↗
• MalfunctionFeb 18, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THERE WERE ISSUES WITH THE ORVIL (ORAL ANVIL) AND EEA STAPLER. THERE WERE SET-UP ISSUES PRIOR TO FIRING, AND THE ORAL ANVIL WAS DIFFICULT TO ATTACH TO THE STAPLER. THE PROCEDURE WAS EXTENDED BY UP TO 30 MINUTES AS THE DEVICES DID NOT CLICK INSIDE THE CAVITY AND WERE TRIED OUTSIDE THE PATIENT. THE DEVICES WERE REPLACED WITH NEW ONES, WHICH FUNCTIONED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392882 ↗
• MalfunctionNov 5, 2024Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL SWITCH (DS) PROCEDURE, THE SAFETY LEVER PUSHED FORWARD BEYOND THE DOCKING LOCATION AND COULD NOT BE PULLED BACKWARD TO TURN OFF SAFETY, PREVENTING THE DEVICE FROM FIRING. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611039 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING GASTRIC ASCENSION, WHEN THE ANASTOMOSIS TO THE ESOPHAGUS WAS PERFORMED, WHEN CLOSING THE STAPLER, A FRACTURE OCCURRED IN THE NECK OF THE ANVIL. ANOTHER OF THE SAME STAPLERS WAS PLACED ON THE TABLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798651 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REVIEW OF SECONDARY DATA SOURCES OF A STUDY ABOUT THE EFFECTIVENESS OF BEDSIDE STAPLERS (BS) COMPARED WITH ROBOTIC STAPLERS (RS) IN BARIATRIC ROBOTIC PROCEDURES INVOLVING 7268 DISCHARGES, PERFORMED BETWEEN (B)(6) 2021, THE FOLLOWING CLINICAL OUTCOME WAS OBSERVED USING AN EXTRA-LARGE 21MM CIRCULAR STAPLERS WITH 3.5MM STAPLES: BLEEDING IN ONE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17830349 ↗
• InjuryDec 5, 2022Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS (ROUX-EN-Y), THE CIRCULAR STAPLER DID NOT PROPERLY STAPLE 360 DEGREES. UPON INSPECTION OF THE ANASTOMOSIS THERE WAS A LARGE HOLE WITHOUT EVIDENCE OF STAPLES HAVING BEEN FIRED FOR 1/3 OF THE CIRCUMFERENCE. A NEW CIRCULAR STAPLER WAS USED AND A REDO OF ANASTOMOSIS WAS PERFORMED.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15920741 ↗
• MalfunctionNov 17, 2022Failure to Form Staple

  EEA STAPLER USED FOR GASTRIC BYPASS ANASTOMOSIS DID NOT PROPERLY STAPLE 360 DEGREES. ON GROSS INSPECTION OF THE ANASTOMOSIS THERE WAS A LARGE HOLE WITHOUT EVIDENCE OF STAPLES HAVING BEEN FIRED FOR 1/3 OF THE CIRCUMFERENCE. NO EVIDENCE OF THE DEVICE BREAKING OR COMING APART IN THE PATIENT, A SECOND DEVICE WAS OBTAINED AND A REPEAT ANASTOMOSIS WAS PERFORMED.

  Patient problems: Failure to Anastomose

  MAUDE report 15813990 ↗
• InjuryNov 7, 2022Failure 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 A LAPAROSCOPIC GASTRIC ROUX-EN-Y JEJUNOSTOMY ANASTOMOSIS, THE STAPLE LINE WAS INCOMPLETE. THE ANASTOMOSIS HAD TO BE RESECTED AND REVISED WITH ANOTHER CIRCULAR STAPLER AS THERE WAS A HOLE IN THE ANASTOMOSIS FROM 9 TO 12 O'CLOCK RESULTING IN A SMALLER THAN INTENDED GASTRIC POUCH AND A SHORTER ROUX LIMB. THAT PATIENT HAD A DRAIN PLACED AS A RESULT OF THE MISHAP. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES TO CORRECT THE PROBLEM. THE PATIENT WILL BE EXTENDED THE HOSPITALIZATION FOR TWO DAYS, INSTEAD OF ONE IF THERE WILL BE NO FURTHER COMPLICATIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15746320 ↗
• MalfunctionOct 29, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC BYPASS REVISION, WHILE CREATING THE ANASTOMOSIS, THE SURGEON PLACED THE ANVIL IN POSITION, ATTACHED THE STAPLER TO ANVIL, CLOSED AND FIRED. THE SURGEON WAS ABLE TO PROVIDE A FULL SQUEEZE WHEN FIRING. WHEN THE STAPLER WAS OPENED, THE SURGEON NOTICED THE ANVIL AND ALL TISSUE WAS COMPLETELY UNAFFECTED. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694981 ↗
• InjuryDec 8, 2021Failure to Form Staple; Detachment of Device or Device Component; Misassembly by Users; Failure to Form Staple; Detachment of Device or Device Component; Misassembly by Users

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC ROUX-EN-Y, DURING ANASTOMOSIS, AN INCORRECT SIZE ORAL ANVIL WAS PAIRED WITH THE HANDLE WHEN USED ON THE FIRST FIRING. THE DEVICE DISENGAGED AND INCOMPLETELY FIRED. A CORRECT DEVICE FROM ANOTHER MANUFACTURER WAS USED TO RESECT AND RE-ANASTOMOSE THE STAPLE LINE TO FIX THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12959677 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN CREATING THE GASTROJEJUNOSTOMY, THE RETRIEVAL SUTURE ON THE ORAL ANVIL DID NOT CUT WHEN THE STAPLER WAS FIRED. THERE WAS DIFFICULTY IN REMOVING THE STAPLER AND ORAL ANVIL FROM THE CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 12229144 ↗
• MalfunctionMar 18, 2021Loss of or Failure to Bond; Device Difficult to Setup or Prepare; Loss of or Failure to Bond; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PRIOR TO USE, ONE OF THE TWO ANVIL TROCAR TIP ACCESSORY (WITH SUTURE) WAS NOT ABLE TO FIX IT INTO THE ANVIL HOLE. THE OTHER ANVIL TROCAR TIP ACCESSORY WITHOUT SUTURE WAS FIXED TO ANVIL PERFECTLY. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515218 ↗
• InjuryDec 15, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SEAL AROUND THE RING DID NOT CLOSE ALL THE WAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11011288 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE FROM LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, WHILE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT, GASTROINTESTINAL BLEEDING (500 CC OR MORE) WAS OBSERVED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR A HIGHER LEVEL OF CARE. THERE WAS TISSUE DAMAGE. BLOOD TRANSFUSION HAD TO BE PERFORMED AND HOSPITALIZATION WAS EXTENDED BY 2-3 DAYS AS A RESULT OF THE EVENT.

  Patient problems: Blood Loss; No Code Available; Tissue Damage

  MAUDE report 10741028 ↗
• InjuryOct 24, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN THE DEVICE WAS FIRED THERE WERE INCOMPLETE STAPLE LINE. TO RESOLVE THE ISSUE THE SURGEON HAD TO OVER-SEW THE TISSUE IN ORDER TO COMPLETE THE CASE. IN ADDITION THE REMOVAL OF THE TUBING-SUTURE ON ORVIL WAS DIFFICULT AND REQUIRED MORE FORCE TO REMOVE.

  Patient problems: No Code Available; Unspecified Tissue Injury

  MAUDE report 10731898 ↗
• MalfunctionJun 19, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A PARTIAL GASTRECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT TO LOAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173703 ↗
• MalfunctionApr 22, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EX-Y PROCEDURE, THE BLADE OF THE DEVICE WAS DULL AND NOT WORKING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9987680 ↗
• MalfunctionFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX PROCEDURE, WHEN PLACING THE ANVIL INTO THE PATIENT'S POUCH, A PIECE OF THE ANVIL'S TROCAR BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS SUCCESSFULLY RETRIEVED NEAR THE SPLEEN AND THE OPERATION CONTINUED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712392 ↗
• InjuryDec 26, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AFTER THE STAPLE WAS FIRED, THE SURGEON STATED THAT THERE WAS AN INCOMPLETE STAPLE LINE. THE SURGEON CUT OFF THE STAPLE LINE AND RE-INSERTED ANOTHER ANVIL ORVIL AND ANOTHER STAPLER TO COMPLETE THE PROCEDURE. THERE WAS AN UNANTICIPATED TISSUE LOSS DUE TO THE REPORTED EVENT.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9519720 ↗
• MalfunctionDec 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS AFTER FIRING, THE ANVIL OF THE STAPLER DISENGAGED INTO PATIENT'S BOWEL. THE SURGEON USED A LAPAROSCOPIC GRASPERS TO REMOVE THE ANVIL THAT FELL OFF IN ORDER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9480248 ↗
• MalfunctionDec 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AFTER ANASTOMOSIS WAS MADE, THE DEVICE'S ANVIL DISENGAGED AND FELL ON THE PATIENT'S CAVITY BUT WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS 30 MINUTES MORE ADDED ON OPERATION TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396250 ↗
• InjuryMay 28, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y, ON GASTRO-JEJUNOSTOMY, A 1CM POSTERIOR LEAK WAS DISCOVERED UPON TESTING AFTER HAVING FIRED THE STAPLER. ANOTHER ORVIL AND STAPLER WAS USED AND THE SAME ISSUE OCCURRED. THE ANASTOMOSIS WAS HAND-SEWN TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 8648423 ↗
• InjuryApr 29, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, DURING GASTROJEJUNOSTOMY, AFTER COMPLETELY FIRING THE STAPLER AND OPENING IT UNTIL A CLICK WAS HEARD THE ANVIL DID NOT TILT. EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE ANVIL THROUGH THE ANASTOMOSIS. DONUTS WERE COMPLETE AND LEAK TEST WAS NEGATIVE. THE SURGEON NEEDED TO OVER SEW THE STAPLE LINE TO REINFORCE THE ANASTOMOSIS.

  Patient problems: No Code Available

  MAUDE report 8560778 ↗
• MalfunctionApr 29, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, WHEN THE PRODUCT WAS TAKEN OUT OF THE BLISTER PACK TO BE USED IN COMBINATION WITH THE ORVIL, WHEN THE TWIT KNOB WAS SLUED, IT CAME OFF. THE CONNECTION PART WAS DISCONNECTED, SO THE DOCTOR TRIED TO PUSH THE KNOB (WHICH CAME OFF) ONCE MORE INTO THE PROJECTION OF THE HANDLE, AND IT SEEMED THAT THE PRODUCT WAS ABLE TO BE USED WITHOUT PROBLEMS BUT THE DOCTOR FELT UNCOMFORTABLE AND HAD A CONCERN, SO THE REPORTED PRODUCT WAS STOPPED USING, AND A NEW PRODUCT WAS OPENED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560092 ↗
• MalfunctionApr 2, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING GASTROJEJUNAL ANASTOMOSIS IN A GASTRIC BYPASS PROCEDURE, THE ANVIL AND STAPLER WAS CONNECTED PER INSTRUCTION. AFTER FIRING THE STAPLER, THE RETRIEVAL SUTURE WAS NOT CUT AND ONLY THE DISTAL DONUT WAS IDENTIFIED ON THE STAPLER UPON INSPECTION. THERE WAS NOT A PROXIMAL DONUT FOUND. AIR WATER LEAK TEST WAS NEGATIVE. THE RETRIEVAL SUTURE WAS CUT TO RELEASE FROM STAPLER/ANVIL. SUBSEQUENT TEST SHOWED ANASTOMOSIS WAS OKAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476400 ↗