EEA EEAXL25Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10884523006056), received between Feb 18, 2016 and Apr 11, 2026 — classified as 5 deaths, 61 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (35 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 13, 2022Open, Classified

   The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

   Z-1322-2022 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING RADICAL SURGERY FOR GASTRIC CANCER, DURING JEJUNAL-ESOPHAGEAL ANASTOMOSIS, THE STAPLER COULD NOT BE FIRED OUT. IT WAS NOTED THAT A MINOR BLEEDING OCCURRED AND THE SURGERY WAS EXTENDED BY APPROXIMATELY ONE HOUR. A NEW STAPLER WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24847963 ↗
• MalfunctionFeb 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC SIGMOID COLECTOMY WITH MOBILIZATION OF SPLENIC FLEXURE INDOCYANINE GREEN (ICG) ANGIOGRAPHY AND SIGMOIDOSCOPY, THE SURGEON FIRED THE STAPLER AS DIRECTED AND WHEN IT WAS BEING PULLED OUT, THE ANVIL DETACHED FROM THE STAPLER AND REMAINED INSIDE THE PATIENT. THE ANVIL WAS THEN SUCCESSFULLY AND SAFELY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284402 ↗
• MalfunctionFeb 2, 2026Failure to Cut

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE ESOPHAGECTOMY, THE CIRCULAR STAPLER AND FIRST ANVIL WOULD NOT CONNECT AND SEAT PROPERLY. A NEW ANVIL WAS OPENED AND IT WAS VERY DIFFICULT TO CONNECT AND SET THE ANVIL TO THE STAPLER. AFTER MUCH TIME, WHICH EXTENDED 45 MINUTES, AND WORKING, THE ORANGE BAND WAS COVERED, THE SAFETY WAS ABLE TO BE RELEASED AND THE SURGEON FIRED THE STAPLER. AS THE SURGEON OPENED, TURNING THE BLACK WING NUT COUNTER CLOCKWISE TWO FULL TURNS, THE SURGEON FELT A CLICK AND REMOVED THE STAPLER FROM THE PATIENT CAVITY. AT THIS TIME THE STAPLER SEPARATED FROM THE ANVIL AND THE ANVIL REMAINED IN THE PATIENTS TISSUE. THE SURGEON WAS ABLE TO PULL IT THROUGH THE ANASTOMOSIS AND REMOVE IT FROM THE PATIENT. IT APPEARED THAT ALL THE STAPLERS WERE FORMED, HOWEVER, ALL OF THE TISSUE WAS NOT CUT. THERE WAS STILL SOME TISSUE AROUND THE ANVIL AND IT APPEARS THE KNIFE BLADE DID NOT FULLY CUT THE TISSUE. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24236179 ↗
• MalfunctionJan 22, 2026

  25MM EEA CIRCULAR STAPLER BEING USED IN PATIENT. SURGEON FIRED STAPLER AS DIRECTED AND WHEN IT WAS BEING PULLED OUT, THE ANVIL DETACHED FROM THE STAPLER AND REMAINED INSIDE THE PATIENT. ANVIL WAS SUCCESSFULLY AND SAFELY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144421 ↗
• MalfunctionDec 12, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC TOTAL GASTRECTOMY, ON THE ESOPHAGOJEJUNOSTOMY, AFTER FIRING THE ANTERIOR WALL SIDE HAD TYPE B INCOMPLETE STAPLE FORMATION. IT WAS NOTED THAT THE STAPLE LINE WAS INCOMPLETE. MANUAL SUTURING WAS PERFORMED TO REINFORCE THE STAPLE LINE. THE SURGERY WAS EXTENDED BY THIRTY MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 23794687 ↗
• InjuryDec 8, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  DUPLICATE OF (B)(4).

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 23743834 ↗
• InjuryDec 8, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, IN DIGESTIVE TRACT RECONSTRUCTION, THE DEVICE PARTIALLY FIRED, WHICH REQUIRED THE INCISION TO BE EXTENDED BY MORE THAN ONE INCH. A THORACOTOMY WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 23743387 ↗
• MalfunctionSep 10, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, ON GASTROJEJUNOSTOMY, 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 23016829 ↗
• InjuryMay 13, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, THE ORAL ANVIL WAS DIFFICULT TO ATTACH TO THE CIRCULAR STAPLER. THE ORAL ANVIL WAS ATTACHED BUT IT WAS LOOSED ON THE INSTRUMENT. THE SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN SURGERY AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Laceration(s)

  MAUDE report 22014776 ↗
• MalfunctionApr 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LAPARO-THORACOSCOPIC IVOR-LEWIS ESOPHAGECTOMY (LEWIS SANTY), THE STAPLES HAD POOR FORMATION AND THE STAPLING QUALITY WAS QUESTIONABLE TO THE SURGEON. THE PATIENT REVEALED A FISTULA REQUIRING AN ADDITIONAL SURGICAL REVISION WHICH IS NOT DUE TO THE DEVICE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21852963 ↗
• MalfunctionFeb 25, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THE GASTRECTOMY, THERE WERE PROBLEMS CONNECTING THE CIRCULAR STAPLER TO THE ORAL ANVIL DEVICE. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH ANOTHER NEW CIRCULAR STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462721 ↗
• MalfunctionFeb 18, 2025Failure to Form Staple; Failure to Cut; Human-Device Interface Problem; Failure to Form Staple; Failure to Cut; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY USING THE STAPLER, THE DEVICE FAILED TO PERFORM AN ANASTOMOSIS AS THE STAPLER APPEARED TO FIRE UNFORMED STAPLES INTO THE GASTRIC CONDUIT. THE DEVICE DID NOT CUT AT ALL AS WELL. THE ANVIL WOULD NOT FULLY EXTEND FROM THE STAPLER AFTER OPENING, MAKING IT IMPOSSIBLE TO SEPARATE THE ANVIL FROM THE STAPLER. AS A RESULT, THE ANASTOMOSIS WAS SEWN ROBOTICALLY AFTER THE DEVICE FAILURE. THE ANVIL AND STAPLER WERE REMOVED VIA EXTENDED ENTEROTOMY OF THE ESOPHAGECTOMY AND GASTRIC CONDUIT. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY.

  Patient problems: Failure to Anastomose; Laceration(s) of Esophagus

  MAUDE report 21405432 ↗
• MalfunctionNov 27, 2024Noise, Audible; Incomplete or Inadequate Connection; Noise, Audible; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY PROCEDURE, TO PERFORM THE ANASTOMOSIS THE SURGEON REQUESTED THE CIRCULAR STAPLER, WHEN JOINING THE CLAMP WITH THE ANVIL BY ADVANCING THE TIP, THE CLAMP MADE A NOISE AND DID NOT MAKE THE JUNCTION. THE SURGEON TRIED AGAIN TWICE WITHOUT SUCCESS. THE ANVIL WAS STILL ATTACHED TO THE ESOPHAGUS AND COULD NOT BE CHANGED. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801109 ↗
• MalfunctionNov 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SELF-SUTURE CLAMP DID NOT STAPLE THE ANASTOMOSIS, REQUIRING THE SELF-SUTURE CLAMP TO BE CHANGED FOR THE ANASTOMOSIS REPAIR. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758098 ↗
• MalfunctionOct 4, 2024Human-Device Interface Problem; Incomplete or Inadequate Connection; Human-Device Interface Problem; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY, THE ORAL ANVIL CAN BE ATTACHED BUT WAS LOOSE ON THE INSTRUMENT. THE ANVIL LEGS WERE BENT. ANOTHER MANUFACTURER'S PRODUCT WAS TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371605 ↗
• MalfunctionSep 16, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY PROCEDURE, 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 20226246 ↗
• MalfunctionAug 8, 2024Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC ESOPHAGECTOMY PROCEDURE, AFTER FIRING, THE CARTRIDGE DISENGAGED FROM THE CIRCULAR STAPLER HEAD WHILE BEING REMOVED THROUGH THE CHEST WALL. NO PIECE FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940414 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A ESOPHAGECTOMY, WHEN CREATING AN ANASTOMOSIS OF THE ESOPHAGUS TO STOMACH, THE STAPLER WAS ABLE TO CUT THE TISSUE, BUT THE STAPLES DID NOT DEPLOY. THE ANASTOMOSIS WAS SUTURE[D TO RESOLVE THE ISSUE. THERE WAS A TWO HOUR EXTENSION OF THE SURGICAL TIME. IT WAS ALSO REPORTED THAT THE CARTRIDGE OF THE DEVICE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19666551 ↗
• InjuryJun 28, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE MINIMALLY INVASIVE ESOPHAGECTOMY, THE CIRCULAR STAPLER DID NOT SEEM TO FIRE CORRECTLY. WHEN TRYING TO CREATE THE ANASTOMOSIS BETWEEN ESOPHAGUS AND STOMACH, THE STAPLER DID NOT SEEM TO DEPLOY ANY STAPLES, ONLY CUT WHICH HAD BAD RESULTS FOR ANASTOMOSIS. THE SURGEON HAD TO CONVERT THE PROCEDURE FROM LAPAROSCOPIC TO OPEN TO GO INTO ABDOMEN TO FURTHER MOBILIZE, AND THEN START THE PROCEDURE AGAIN WITH A DIFFERENT CIRCULAR STAPLER. THE SURGICAL TIME WAS EXTENDED FOR SIX HOURS. THE PATIENT WAS CURRENTLY IN INTENSIVE CARE UNIT DUE TO VENTRICULAR FIBRILLATION.

  Patient problems: Failure to Anastomose; Foreign Body In Patient; Laceration(s); Ventricular Fibrillation

  MAUDE report 19638529 ↗
• InjuryMay 9, 2024Break; Difficult to Remove; Failure to Fire; Detachment of Device or Device Component; Packaging Problem; Break; Difficult to Remove; Failure to Fire; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CLOSURE OF END-COLOSTOMY WITH ANASTOMOSIS TO COLON PROCEDURE, WHILE RECONNECTING TH E COLON WITH A CIRCULAR STAPLER, A BIG CRACK APPEARED IN THE STAPLER WHEN THE SURGEON FIRED IT, AND THE PLASTIC FROM THE STAPLER FELL INTO THE PATIENT'S CAVITY. ALL THE PIECES WERE RETRIEVED. THERE WAS DIFFICULTY REMOVING THE STAPLER FROM THE CAVITY, AND DUE TO THE STAPLER BREAKING DOWN, IT WAS VERY HARD TO REMOVE. THERE WAS A TEAR IN THE MESORECTAL AREA UPON REMOVAL OF THE STAPLER. TO RESOLVE THE ISSUE, A NEW STAPLER WAS USED, AND THE TORN TISSUE WAS SUTURED. THE SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT PROBLEM. THE EVENT LED TO OR EXTENDED THE PATIENT'S HOSPITALIZATION. UPON INSPECTION THERE WERE FOUND SEVERE DAMAGE TO THE OUTER-PACKAGING MATERIAL. INNER PACKING WAS NOT VISUALLY DAMAGED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19282287 ↗
• MalfunctionApr 11, 2024Break; Failure to Form Staple; Detachment of Device or Device Component; Human-Device Interface Problem; Noise, Audible; Break; Failure to Form Staple; Detachment of Device or Device Component; Human-Device Interface Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING AN IVOR LEWIS ESOPHAGECTOMY PROCEDURE, WHEN PERFORMING THE ANASTOMOSIS, THE SURGEON WAS SQUEEZING THE HANDLE STATING THAT THE SAFETY WAS NOT LETTING GO. THE SURGEON KEPT SQUEEZING, A SNAP WAS HEARD AND THE SAFETY LEVER BROKE. ALL PIECES OF THE LEVER WAS FOUND. THE SURGEON KEPT USING THE STAPLER, WHEN THE HANDLE WAS SQUEEZED, THE USUAL CRUNCH SOUND WAS NOT HEARD. WHEN THE STAPLER WAS PULLED THE ANVIL WAS STILL ATTACHED, AND THE TISSUE RINGS WERE INTACT, BUT THE RING PART OF THE STAPLER WAS MISSING. FURTHER DISSECTION WAS REQUIRED TO DO ANOTHER ANASTOMOSIS, AND WHILE DOING IT, THEY FOUND INSIDE THE PATIENT A FULL RING OF STAPLES LOOSE AS THE STAPLES DID NOT FORM PROPERLY AND THE RING PART OF THE STAPLER WHERE IT ATTACHES TO THE ANVIL.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19088460 ↗
• MalfunctionMar 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC GASTRECTOMY, ANATOMICAL ALIGNMENT IN THE PATIENT MADE IT DIFFICULT FOR THE ANVIL AND STAPLER TO MATE; THE SURGEON HAD TO USE EXCESS STRENGTH TO MATE THE ANVIL AND STAPLER. ONCE MATED, THE STAPLE LINE WAS SUCCESSFULLY IMPLEMENTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967734 ↗
• MalfunctionFeb 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY, THERE WAS EXCESSIVE DIFFICULTY CONNECTING THE ORAL ANVIL TO THE CIRCULAR STAPLER. THE ISSUE WAS RESOLVED WHEN THE CIRCULAR STAPLER AND THE ORAL ANVIL EVENTUALLY CONNECTED AND DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789337 ↗
• MalfunctionFeb 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY, MATING OF THE ANVIL TO THE TWO CIRCULAR STAPLERS WAS UNSUCCESSFUL. ANCHORING SUTURE DISENGAGED UNDER NORMAL TENSION AND ALSO UNABLE TO SUCCESSFULLY MATE THE THREE ORVILS WITH THE ANVIL SHAFT AND GRASPING NOTCH VISIBLE AND ACCESSIBLE. THE SURGEON HAD TO ABORT MULTIPLE ATTEMPTS AT STAPLED ANASTOMOSIS AND CONVERTED TO HAND-SEWN ANASTOMOSIS, WHICH EXTENDED THE SURGICAL TIME TO 90 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764110 ↗
• MalfunctionFeb 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY, MATING OF THE ANVIL TO THE TWO CIRCULAR STAPLERS WAS UNSUCCESSFUL. ANCHORING SUTURE DISENGAGED UNDER NORMAL TENSION AND ALSO UNABLE TO SUCCESSFULLY MATE THE THREE ORVILS WITH THE ANVIL SHAFT AND GRASPING NOTCH VISIBLE AND ACCESSIBLE. THE SURGEON HAD TO ABORT MULTIPLE ATTEMPTS AT STAPLED ANASTOMOSIS AND CONVERTED TO HAND-SEWN ANASTOMOSIS, WHICH EXTENDED THE SURGICAL TIME TO 90 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764100 ↗