EEA TRIEEA28MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 511 adverse event reports that list this exact device (DI 10884521593022), received between Apr 18, 2018 and Sep 29, 2026 — classified as 4 deaths, 236 injuries, 271 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (129 reports).

1 other recall cover devices cleared under the same FDA submission (K172361, K221005); they may or may not involve this specific model.

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 511 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that during an end-to-end anastomosis procedure, holes were discovered during the air leak test. The device was replaced to resolve the issue and the surgical time was extended.

  Patient problems: Failure to Anastomose

  MAUDE report 50936711 ↗
• MalfunctionSep 21, 2026Misfire

  It was reported that after successful firing of the circular Stapler, an issue involving the purstring device occurred. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839265 ↗
• MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50782029 ↗
• MalfunctionSep 14, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764176 ↗
• MalfunctionAug 18, 2026Failure to Form Staple

  Patient problems: Failure to Anastomose

  MAUDE report 50311742 ↗
• MalfunctionAug 18, 2026Misfire; Failure to Form Staple

  Patient problems: Failure to Anastomose

  MAUDE report 50306424 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  According to the reporter, post-operatively of a procedure in (b)(6) 2026 where a circular stapler was used, the patient had elevated leukocyte but was in good spirits. The next day, leukocyte counts rose further, C-reactive protein (CRP) was high, and the patient experienced pain and bleeding. The next day, when the surgeon viewed the CT scan, a large mass was visible, prompting a decision to reoperate the patient. Upon lifting the colon during reoperation, the anastomosis was observed to be open. The patient had an early anastomotic dehiscence involving 70¿80% of the anastomosis circumference. Consequently, the surgeon decided to transect the colon and create a temporary ileostomy. The surgeon noted that the descended colon was viable, well-perfused, and tension-free, and that there was a dissecting hematoma in the wall. The patient¿s hospital stay was extended as a result.

  Patient problems: Blood Protein Abnormal; Failure to Anastomose; Hematoma; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count; Pain; Unintended Radiation Exposure; Wound Dehiscence

  MAUDE report 50303567 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220096 ↗
• MalfunctionAug 11, 2026Failure to Form Staple

  It was reported that during a laparoscopic right hemicolectomy procedure, in performing the anastomosis between the transverse colon and right colon. Poor staple formation was noted in approximately one-quarter of the staple, with excessive tissue incorporated. To resolve the issue, the anastomosis was reinforced with sutures.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50210265 ↗
• MalfunctionAug 6, 2026Misfire

  Patient problems: Failure to Anastomose

  MAUDE report 50160748 ↗
• MalfunctionAug 6, 2026Misfire

  Patient problems: Failure to Anastomose

  MAUDE report 50160620 ↗
• MalfunctionJul 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COLORECTAL SURGERY, AT THE END OF THE PROCEDURE, WHEN THE CIRCULAR STAPLER WAS USED, THE ANVIL REMAINED INSIDE THE PATIENT UPON WITHDRAWAL OF THE STAPLER THROUGH THE ANUS. THE SURGEON PERFORMED AN ADDITIONAL MANEUVER TO RETRIEVE THE ANVIL FROM THE RECTUM USING FORCEPS, WHICH CARRIED A HIGHER RISK OF MUCOSAL INJURY. THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798127 ↗
• MalfunctionJul 10, 2026Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESECTION, WHEN USING THE DEVICE FOR JEJUNOCOLIC ANASTOMOSIS, THE PRODUCT DIAMETER WAS TOO LARGE. TO RESOLVE THE ISSUE, ANOTHER CIRCULAR STAPLER WITH A SMALLER SIZE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779061 ↗
• MalfunctionJul 9, 2026Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER THE ANASTOMOSIS OF THE TWO SEGMENTS OF THE DIGESTIVE TRACT, THE ANVIL DID NOT TIP OVER AND IT REMAINED IN THE DIGESTIVE TRACT. THE ANVIL WAS DIFFICULT TO REMOVED AND BY PRESSING ON THE WALL OF THE DIGESTIVE TRACT AND POINTING IT TOWARDS THE ANUS, THE ANVIL WAS ABLE TO BE REMOVED BY THE SURGEON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25772934 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER FIRING, THE ANVIL CAME LOOSE BEFORE REMOVING THE STAPLER FROM THE RECTUM. AS THE RECTUM WAS LOW (2CM), THE SURGEON MANAGED TO TAKE THE ANVIL OUT OF THE ANUS WITH FORCEPS. AN INTRAOPERATIVE RECTOSCOPY WAS PERFORMED TO VERIFY THE INTACT STAPLE LINE. THE SURGICAL TIME WAS EXTENDED FOR 50 MINUTES DUE TO THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541851 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POSTOPERATIVELY, THE PATIENT HAD EMERGENCY SURGICAL REVISION DUE ANASTOMOTIC STAPLE-LINE SEPARATION OF THE FISTULA. HOSPITALIZATION WAS EXTENDED AS A RESULT OF THIS EVENT.

  Patient problems: Failure to Anastomose; Fistula

  MAUDE report 25397910 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC TOTAL MESORECTAL EXCISION WITH A POUCH AND CREATION OF AN ULTRA-LOW COLORECTAL ANASTOMOSIS (APPROXIMATELY 2.5 CM FROM THE ANUS) USING A CIRCULAR STAPLER, THE ANVIL CONNECTED TO THE SHAFT WITH VERY LITTLE RESISTANCE AND THEN DISCONNECTED VERY EASILY DURING TIGHTENING. A SECOND STAPLER WAS OPENED AND THE SAME LOW-RESISTANCE CONNECTION AND EASY DISCONNECTION OCCURRED WHEN ATTEMPTING TO CONNECT IT WITH THE TIED-IN ANVIL. THE TIED-IN ANVIL WAS THEN REMOVED AND REPLACED WITH THE ANVIL FROM THE SECOND STAPLER, AND THE LOW-RESISTANCE CONNECTION AND DISCONNECTION ISSUE PERSISTED. A THIRD STAPLER WAS OPENED AND THE SECOND ANVIL WAS REPLACED WITH THE THIRD ANVIL, AFTER WHICH THE CONNECTION WAS SUCCESSFUL. AFTER FIRING, THE INSTRUMENT WAS OPENED BY TWO FULL ROTATIONS UNTIL A CLICK WAS HEARD; HOWEVER, DURING WITHDRAWAL THE ANVIL DISCONNECTED AND HAD TO BE RETRIEVED. THE ANASTOMOSIS WAS REPORTED TO BE COMPLETE AND AIRTIGHT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231612 ↗
• MalfunctionMay 7, 2026Failure to Align; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SIGMOID COLECTOMY, AT THE TIME OF ANASTOMOSIS AT THE SIGMOID COLON, THE STAPLER WAS DOCKING WITH THE ANVIL AND TIGHTENED UNTIL THE END, BUT DUE TO THE SITUATION OF THE PATIENT'S TISSUE, IT WAS RELEASED ONCE. DOCKING WAS PERFORMED AGAIN AND RE-TIGHTENED, BUT AT THAT TIME, THE ANVIL WAS TILTED. IT WAS NOTED THAT THE ANVIL WAS DETACHED AND NO FALLEN PARTS OR BROKEN PIECES FELL INTO THE PATIENT'S BODY. A NEW ONE OF THE SAME PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114282 ↗
• MalfunctionApr 18, 2026Device Slipped

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, WHEN CLAMPING THE TISSUE, THE CIRCULAR STAPLER COULD NOT BE CLOSED. UNUSUAL EFFORT WAS REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. ANOTHER CIRCULAR STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918969 ↗
• MalfunctionApr 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLON RESECTION ON A SIGMOID COLON-TO-RECTUM ANASTOMOSIS, ABNORMAL B-SHAPE STAPLE FORMATION WAS OBSERVED. THE STAPLE LINE WAS REPAIRED BY OVERSEWING/LOCKING EDGE SUTURING TO COMPLETE THE PROCEDURE.

  Patient problems: Failure to Anastomose

  MAUDE report 24897474 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE WEEK POST-OPERATIVE OF A PROCEDURE WHERE A CIRCULAR STAPLER WAS USED, AN ANASTOMOTIC LEAK WAS DISCOVERED. THE PATIENT HAD SEPSIS AND BAD VITALS. THE SURGEON DID A COMPUTED TOMOGRAPHY (CT) SCAN, BUT DID NOT SEE LEAKAGE. THE LEAKAGE WAS DISCOVERED WHEN A GREENISH MATERIAL CAME OUT INTO THE DRAIN TUBING. THE PATIENT WAS REOPERATED, AND IT WAS FOUND THAT HALF OF THE CIRCUMFERENCE OF THE STAPLE LINE HAD OPENED. THE STAPLE LINE WAS RESECTED AND RE-ANASTOMOSED BY HAND-SUTURING. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND THEIR HOSPITALIZATION WAS EXTENDED FOR ABOUT ONE MONTH.

  Patient problems: Failure to Anastomose; Sepsis; Unintended Radiation Exposure

  MAUDE report 24678502 ↗
• MalfunctionMar 19, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW RECTAL CANCER RADICAL RESECTION, THE CIRCULAR STAPLER WAS USED FOR ANASTOMOSIS BETWEEN THE RECTUM AND SIGMOID COLON. POOR B-SHAPED STAPLE FORMATION WERE OBSERVED, AND EXCESSIVE TISSUE WAS INCORPORATED INTO THE BARREL OF THE STAPLER. ADDITIONAL SUTURING WAS REQUIRED TO ADDRESS ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24637999 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SAFETY LEVER BROKE AND DISENGAGED. THE STAPLER DID NOT JOIN THE BOWEL TOGETHER AS THE RED SAFETY GUARD FELL OFF. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611866 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD AN ANASTOMOTIC LEAKAGE. THE PATIENT WAS REOPERATED FOR WASHING AND IT WAS OBSERVED THAT ¾ OF THE ANASTOMOSIS HAS OPENED UP THOUGH THE STAPLES WERE STILL INTACT ON THE TISSUE. THE STAPLE LINE WAS RESECTED AND HAND-SUTURED TO RESOLVE THE ISSUE. THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT¿S HOSPITAL STAY WAS ALSO EXTENDED FOR A FEW WEEKS.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24536908 ↗
• MalfunctionFeb 27, 2026Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RADICAL RECTAL CANCER SURGERY, THE CIRCULAR STAPLER WAS USED TO ANASTOMOSE THE SIGMOID AND THE RECTUM. AFTER FIRING, SOME POORLY FORMED STAPLES WERE FOUND. THERE WAS EXCESSIVE TISSUE INCORPORATED INTO THE BARREL OF THESTAPLER AND THE DONUTS WERE NOT COMPLETE. SUTURES WERE APPLIED TO OVERSEW THE STAPLE LINE.

  Patient problems: Failure to Anastomose

  MAUDE report 24475460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172361, K221005. One submission often covers many models, so check the product and lot details in each record.

• Z-0070-2019 · Aug 17, 2018 · Terminated
  EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a