EEA EEAXL2535Recalls & reported problems

Summary

The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 10884523006124), received between Apr 22, 2016 and Mar 19, 2026 — classified as 1 death, 100 injuries, 131 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (43 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 232 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Mechanical Jam

  ACCORDING TO THE REPORTER, DURING ESOPHAGOGASTRIC ANASTOMOSIS, THE ORAL ANVIL WAS ATTACHED TO THE STAPLER; HOWEVER, THE ANVIL DID NOT CHANGE FROM THE TILTED POSITION TO THE NORMAL (UPRIGHT) POSITION AT THE TIME OF ANASTOMOSIS. DESPITE ATTACHING AND DETACHING IT SEVERAL TIMES, THE ANVIL POSITION DID NOT CHANGE DURING FIRING. THE ANVIL HEAD OF THE ORAL ANVIL DID NOT RETURN TO THE UPRIGHT POSITION. AS A RESULT, THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY, EXTENDING THE SURGICAL TIME BY MORE THAN 60 MINUTES. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 24645381 ↗
• MalfunctionDec 30, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE AT THE GASTRO-JEJUNOSTOMY STEP, THE ORAL ANVIL WAS DIFFICULT TO ATTACH TO THE DEVICE. THE SURGICAL TEAM WAS UNABLE TO GET THE STAPLER TO ATTACH TO THE ORAL ANVIL, AS IT SEEMED TO STICK AND WOULD NOT RIGHT THE ANVIL. THE CIRCULAR STAPLER WAS REPLACED, AND THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926210 ↗
• MalfunctionNov 24, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC LOWER ANTERIOR RESECTION, DURING THE END-TO-END ANASTOMOSIS OF THE COLON, THE CIRCULAR STAPLER CUT BUT DID NOT STAPLE THE TISSUE. THE STAPLES CAME OUT BUT HAD REMAINED ON TOP OF THE CARTRIDGE UNFORMED. THE TISSUE WAS RESECTED AND RE-STAPLED USING A NEW STAPLER.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23633191 ↗
• MalfunctionNov 18, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING THE GASTRIC BYPASS, THE CIRCULAR STAPLER FAILED TO FIRE STAPLES WHEN THE FIRING MECHANISM WAS ACTIVATED. ALTHOUGH THE CUTTING BLADE ADVANCED, NO STAPLES WERE DEPLOYED. THE DEVICE WAS CAREFULLY OPENED AND REMOVED AND INSPECTION CONFIRMED THAT NO STAPLES HAD BEEN FIRED. THE PROCEDURE WAS EXTENDED BY 60 MINUTES AS A RESULT. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE.

  Patient problems: Failure to Anastomose

  MAUDE report 23585535 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE EXPLORATORY LAPAROTOMY WITH REVERSAL OF ILEOSTOMY UTILIZING AN ILEORECTAL ANASTOMOSIS AND LYSIS OF I NTRA-ABDOMINAL ADHESIONS, RIGID PROCTOSCOPY, WHEN THE STAPLER WAS REMOVED FROM THE RECTUM, THE ANVIL CAME APART FROM THE PROXIMAL STAPLER AND THE ANVIL WAS LEFT AT THE ANASTOMOSIS. A RIGID SIGMOIDOSCOPE AND BIOPSY FORCEPS WERE USED TO GRASP THE ANVIL AND REMOVE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569237 ↗
• InjuryNov 10, 2025Failure to Form Staple; Incomplete or Inadequate Connection; Failure to Form Staple; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A THORACIC SURGERY, THE SURGEON PASSED A 23-MM CIRCULAR STAPLER THROUGH THE ESOPHAGUS TO THE GASTRIC FUNDUS, LOCATED THE ANASTOMOSIS SITE AND OPENED IT, AND THEN ASSEMBLED THE CIRCULAR STAPLER, WHICH WAS DIFFICULT TO CLICK; THE ORANGE SEGMENT WAS FELT AND HIDDEN. THE APPROXIMATION BEGAN, AND THE SUTURE FELT DISASSEMBLED. THE SURGEON DECIDED TO STOP AND WITHDRAW THE STAPLER. INDEED, THE ANVIL WAS OBSERVED WITH UNASSEMBLED STAPLES. THE SURGEON RESTARTED THE PROCESS, REASSEMBLED IT AGAIN WITH DIFFICULTY UNTIL THE ORANGE SEGMENT WAS HIDDEN, AND THE SHOT WAS FIRED. UPON REMOVING THE STAPLER, THE ANASTOMOSIS WAS OBSERVED TO BE COMPLETELY OPEN, WITH NO STAPLES FORMED, AND THE ANVIL WAS DISPLACED AGAIN. THE SURGICAL TIME WAS EXTENDED BY THREE HOURS. THE HOSPITALIZATION WAS ALSO EXTENDED.

  Patient problems: Failure to Anastomose

  MAUDE report 23519318 ↗
• InjuryNov 10, 2025Failure to Form Staple; Incomplete or Inadequate Connection; Failure to Form Staple; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A THORACIC SURGERY, THE SURGEON PASSED A 23-MM CIRCULAR STAPLER THROUGH THE ESOPHAGUS TO THE GASTRIC FUNDUS, LOCATED THE ANASTOMOSIS SITE AND OPENED IT, AND THEN ASSEMBLED THE CIRCULAR STAPLER, WHICH WAS DIFFICULT TO CLICK; THE ORANGE SEGMENT WAS FELT AND HIDDEN. THE APPROXIMATION BEGAN, AND THE SUTURE FELT DISASSEMBLED. THE SURGEON DECIDED TO STOP AND WITHDRAW THE STAPLER. INDEED, THE ANVIL WAS OBSERVED WITH UNASSEMBLED STAPLES. THE SURGEON RESTARTED THE PROCESS, REASSEMBLED IT AGAIN WITH DIFFICULTY UNTIL THE ORANGE SEGMENT WAS HIDDEN, AND THE SHOT WAS FIRED. UPON REMOVING THE STAPLER, THE ANASTOMOSIS WAS OBSERVED TO BE COMPLETELY OPEN, WITH NO STAPLES FORMED, AND THE ANVIL WAS DISPLACED AGAIN. THE SURGICAL TIME WAS EXTENDED BY THREE HOURS. THE HOSPITALIZATION WAS ALSO EXTENDED.

  Patient problems: Failure to Anastomose

  MAUDE report 23519273 ↗
• MalfunctionSep 17, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS, WHEN TRYING TO RELEASE THE INTRODUCER IN THE ABDOMEN, IT WOULD NOT RELEASE. A NEW CIRCULAR STAPLER WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 23072391 ↗
• MalfunctionSep 13, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SET UP PRIOR TO FIRING, THE SURGEON WAS UNABLE TO ATTACH THE ANVIL TO THE TROCAR TIP OF THE CIRCULAR STAPLER. AFTER MORE THAN HALF AN HOUR OF UNSUCCESSFUL ATTEMPTS, THE SURGEON DECIDED TO USE A COMPLETELY NEW SET OF CIRCULAR STAPLER HANDLE AND ORAL ANVIL. BY THAT TIME, THE OPENING IN THE STOMACH HAD ALREADY BEEN SIGNIFICANTLY WIDENED DUE TO REPEATED MANIPULATION OF THE ANVIL. WITH THE NEW SET, THE CONNECTION WAS SUCCESSFUL IMMEDIATELY. THE SURGEON HAD TO PLACE ADDITIONAL SUTURES TO REDUCE THE SIZE OF THE ORAL ANVIL ACCESS POINT IN THE STOMACH.

  Patient problems: Tissue Breakdown

  MAUDE report 23045844 ↗
• MalfunctionJun 7, 2025Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY, THE CIRCULAR STAPLER DID NOT FIRE COMPLETELY AND THE STAPLES HAD POOR FORMATION. THE DONUT WAS ALSO INCOMPLETE. THE SURGEON HAND SEWN THE TISSUE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22163172 ↗
• MalfunctionApr 3, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, IN A ROBOTIC ASSISTED ESOPHAGECTOMY, THE SURGEON ATTEMPTED TO INITIATE ANASTOMOSIS OF THE ESOPHAGUS AFTER ESOPHAGEAL CANCER EXCISION USING THE CIRCULAR STAPLER. THE ANVIL WOULD NOT CONNECT TO THE STAPLER AND THE SURGEON WAS UNABLE TO FIRE STAPLER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769679 ↗
• MalfunctionMar 14, 2025

  SURGEON ATTEMPTED TO INITIATE ANASTOMOSIS OF ESOPHAGUS AFTER ESOPHAGEAL CANCER EXCISION USING CIRCULAR STAPLER AND ANVIL. THE ANVIL WOULD NOT CONNECT TO THE STAPLER AND THE SURGEON WAS UNABLE TO FIRE STAPLER. NEW DEVICE WAS USED SUCCESSFULLY, NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605124 ↗
• MalfunctionJan 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THERE WERE FIRING ISSUES WITH THE CIRCULAR STAPLER, SPECIFICALLY DURING THE STAPLING OF THE GASTROJEJUNOSTOMY. THE SURGEON SEEMED TO THINK NOT ALL STAPLES WERE PRESENT IN THE CIRCULAR STAPLER, OR DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES. ALTHOUGH STAPLES WERE PRESENT IN THE CARTRIDGE, THEY DID NOT DEPLOY AS EXPECTED. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 21074698 ↗
• MalfunctionNov 21, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY, DURING ANASTOMOSIS THE CIRCULAR STAPLER WAS NOT FIRED PROPERLY. INCOMPLETE STAPLER FORMATION. SUTURING WAS DONE AS A STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 20746428 ↗
• MalfunctionNov 19, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY PROCEDURE, THE STAPLES DID NOT DEPLOY AND CUT THE TISSUE. ADDITIONALLY, THE STAPLE CARTRIDGE DISENGAGED BUT DID NOT FALL INTO THE CAVITY. TO RESOLVE THE ISSUE, SUTURE WAS USED AS STAPLE LINE REPLACEMENT. IT WAS NOTED THE PROCEDURE EXTENDED FOR ONE HOUR.

  Patient problems: Tissue Breakdown

  MAUDE report 20729347 ↗
• MalfunctionNov 10, 2024Break; Detachment of Device or Device Component; Mechanics Altered; Break; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER CARTRIDGE BROKE AND FELL INTO THE CAVITY. ALL THE BROKEN PIECES WERE RETRIEVED WITH GRASPERS. THE SURGEON HAD TO DO A SECOND ANASTOMOSIS WITH ANOTHER STAPLER AS THE FIRST STAPLER CUT BUT DID NOT STAPLE. THE SURGICAL PROCEDURE WAS EXTENDED FOR AN HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 20649310 ↗
• MalfunctionOct 30, 2024Difficult to Remove; Failure to Form Staple; Failure to Cut; Positioning Problem; Difficult to Remove; Failure to Form Staple; Failure to Cut; Positioning Problem

  ACCORDING TO THE REPORTER, DURING ESOPHAGOJEJUNOSTOMY (ESOPHAGEAL ANASTOMOSIS), AFTER FIRING AN ATTEMPT WAS MADE TO TURN THE WINGNUT, BUT IT ONLY TURNED ABOUT 1/4 OF THE WAY. WITHOUT ALSO REMOVING THE DEVICE, THE OPERATION WAS CONTINUED FOR ABOUT 20 MINUTES. AS A RESULT, ALTHOUGH THE ORAL ANVIL DID NOT COMPLETELY COLLAPSE, REMOVAL WAS PERFORMED AS IS. UPON CHECKING THE ANASTOMOSIS SITE, PART OF THE STAPLE WAS FOUND TO HAVE REMAINED IN U-SHAPE. AGAIN, THE ESOPHAGUS WAS RESECTED, AND THE ANASTOMOSIS WAS COMPLETED USING THEORAL ANVIL. THE ORAL ANVIL WAS PLACED ON THE LEFT SIDE OF THE ESOPHAGEAL STAPLE LINE AND CONNECTED TO THE GENERATOR. THE STAPLE LINE WAS NOT CUT, A 0.5 CM HOLE WAS MADE WITH AN ELECTROCAUTERY AND REMAINED INTACT. NO SUTURES WERE PLACED ON THE ESOPHAGUS. THE ELEVATED JEJUNUM WAS WRAPPED ON THE SIDE WITH VESSEL TAPE. IT WAS ALSO NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR ONE HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 20567650 ↗
• MalfunctionSep 25, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SURGEON DISCONNECTED THE NASOGASTRIC TUBE FROM THE ORVIL AND ATTEMPTED TO MATE TO THE CIRCULAR STAPLER ON THE BACK TABLE AS A TRIAL RUN BUT THE USER WAS UNABLE TO MATE THE TWO COMPONENTS AND HAND-SEWED THE ANASTOMOSIS. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20300991 ↗
• MalfunctionJul 12, 2024Loss of or Failure to Bond; Break; Detachment of Device or Device Component; Incomplete or Inadequate Connection; Loss of or Failure to Bond; Break; Detachment of Device or Device Component; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A GASTRIC RESECTION, THE ANVIL WAS PLACED TRANS-ORALLY SUCCESSFULLY. HOWEVER, SURGICAL TEAM WAS NOT ABLE TO MATE THE STAPLER WITH THE ORAL ANVIL. THE USER WERE NOT ABLE TO APPLY THE FORCE NEEDED TO COMPLETELY MATE THE TWO ITEMS. THE SURGEON MADE THE DECISION TO REMOVE THE ORAL ANVIL TRANS-ORALLY AND START FRESH WITH A NEW ORAL ANVIL. WHILE THE SURGEON WAS REMOVING THE ANVIL USING THE "ADVANCING PROXIMAL GUIDE SUTURE", THE SUTURE BROKE FREE OF THE ANVIL, LEAVING THE ANVIL LODGED IN THE PATIENT'S ESOPHAGUS. THE SURGEON USED AN ENDOSCOPE AND SNARE TO LASSO THE ANVIL AND FINALLY REMOVE IT FROM THE PATIENT. THE SURGICAL TIME WAS EXTENDED FOR OVER AN HOUR. THE NEW ORAL ANVIL AND CIRCULAR STAPLER WORKED AND THE ANASTOMOSIS WAS COMPETED WITH SUCCESS.

  Patient problems: Insufficient Information

  MAUDE report 19735776 ↗
• MalfunctionJun 17, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC ESOPHAGECTOMY, AFTER FIRING THE STAPLER, IT APPEARED THAT SOME OF THE TISSUE MUST HAVE SLIPPED OUT AND DID NOT GET FULLY STAPLED IN, WITH THE ANASTOMOSIS APPEARING TO HAVE LEFT A HOLE. THE STAPLER FIRED OKAY AND WAS ABLE TO BE PULLED OUT SMOOTHLY. THE SURGEON OVERSEWED WHERE THE HOLE WAS, AND THEN THE ANASTOMOSIS LOOKED OKAY AFTER SCOPING THE PATIENT, WHICH EXTENDED THE SURGICAL TIME BY MORE THAN 30 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19548520 ↗
• MalfunctionMay 20, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC ASSISTED TOTAL GASTRECTOMY, THE PLASTIC TUBING CAME OFF OF THE ORAL ANVIL ON INSERTION INTO THE ESOPHAGUS. THE ORAL ANVIL WAS ABLE TO BE POSITIONED IN THE ESOPHAGUS, BUT THE STAPLER WAS UNABLE TO MATE WITH IT. THE RESCUE SUTURE FAILED TO REMOVE THE ORAL ANVIL FROM THE ESOPHAGUS, SO THE ORAL ANVIL WAS CUT OUT, DELIVERED THROUGH THE STOMACH, AND TRANSECTED OUT OF THE ESOPHAGUS. THE ANASTOMOSIS WAS HAND-SEWN. THE SURGICAL TIME EXTENDED 30 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19353194 ↗
• MalfunctionMay 13, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY,  THE STAPLES WERE BROKEN. THE SURGEON TRIED ANOTHER WAY TO PERFORM THE ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose

  MAUDE report 19305612 ↗
• MalfunctionApr 24, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE DEVICE MISFIRED TWICE. THE ANASTOMOSIS WAS COMPLETELY DISRUPTED. THERE WERE INJURIES IN THE STOMACH AND SMALL INTESTINES WHICH WAS REPAIRED DURING THE SAME PROCEDURE. THE ANASTOMOSIS WERE COMPLETED USING SUTURES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19175403 ↗
• MalfunctionMar 13, 2024Loss of or Failure to Bond; Device Slipped; Loss of or Failure to Bond; Device Slipped

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL PROCEDURE, THE DEVICE WAS ULTIMATELY UNABLE TO BE LOADED. IT WAS NOTED THAT SIZERS WERE USED. A DIFFERENT ANVIL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18898485 ↗
• MalfunctionFeb 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKING WAS OPENED IT WAS FOUND OUT THAT THE DEVICE WAS CRACKED. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803188 ↗