EEA EEA2135Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884523004724), received between Oct 27, 2017 and Apr 21, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ESOPHAGECTOMY, THE SAFETY LEVER BROKE. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938499 ↗
• MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ANVIL WAS SEPARATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062950 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT THE CIRCULAR SINGLE-USE STAPLER INSTRUMENT BROKE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922810 ↗
• InjuryDec 11, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROXIMAL PANCREATICODUODENECTOMY PROCEDURE, AT THE TIME OF JEJUNOJEJUNOSTOMY (BRAUN ANASTOMOSIS), THE TISSUE WAS CUT, BUT THE STAPLES DID NOT DEPLOY. THE SURGEON EXTENDED THE INCISION BY LESS THAN 1 INCH AND USED SUTURE TO COMPLETE THE INTESTINAL ANASTOMOSIS. AFTERWARDS, WHEN A PLANNED X-RAY WAS PERFORMED TO CHECK IF THERE WAS ANY REMAINED GAUZE AFTER ABDOMINAL CLOSURE, THE RESULT SHOWED THAT THERE WERE U-SHAPED STAPLES IN THE INTESTINAL TRACT. NO ADDITIONAL SURGERY WAS PLANNED TO REMOVE THE STAPLES IN THE INTESTINAL TRACT.

  Patient problems: Failure to Anastomose; Foreign Body In Patient; Laceration(s); Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 18302654 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED EARLY POSTOPERATIVE BLEEDING IN PATIENTS WHO UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BY-PASS BETWEEN JANUARY 1999 AND APRIL 2020. THE GASTROJEJUNOSTOMY WAS PERFORMED USING A 21-MM CIRCULAR STAPLER WITH THE ANVIL INSERTED TRANS-ORALLY, USING TWO-ROW 3.5-MM HEIGHT STAPLES. THERE WERE 2639 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED: BLEEDING, LEAK, INTRA-ABDOMINAL INFECTION. INTRA-LUMINAL BLEEDING (ILB) RELATED TO BLEEDING FROM THE STAPLE-LINES OR AN ACUTE MARGINAL ULCER AT THE GASTROJEJUNOSTOMY (GJ), WHEREAS EXTRA-LUMINAL BLEEDING (ELB) REFERS TO BLEEDING OCCURRING IN THE ABDOMINAL CAVITY OR FROM THE PORT-SITES. DIAGNOSIS FOR BLEEDING INCLUDED UPPER GASTROINTESTINAL ENDOSCOPY AND COMPUTERIZED TOMOGRAPHY (CT) SCAN. MEDICATIONS (WITHDRAWAL OF ANTICOAGULANT MEDICATION, HEMODYNAMIC SUPPORT, PROCOAGULANTS), BLOOD TRANSFUSIONS ON 41 PATIENTS AND URGENT REOPERATIONS FOR 23 WERE REQUIRED TO TREAT BLEEDING. TWO REOPERATIONS REQUIRED CONVERSION TO OPEN SURGERY, AND THE OTHER 21 WERE COMPLETED LAPAROSCOPICALLY. HOSPITAL STAY WAS EXTENDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Septic Shock; Unspecified Infection

  MAUDE report 15978759 ↗
• MalfunctionJul 7, 2021Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY, THE DEVICE WAS DIFFICULT TO OPEN. THE ANVIL WOULD NOT TILT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12132489 ↗
• MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, WHEN THE DONUT-SHAPED TISSUE WAS REMOVED FROM THE ANVIL AFTER ANASTOMOTIS AND THE TISSUE WAS CHECKED, THERE WAS A PIECE OF METAL THAT SEEMED TO BE A PART OF THE ANVIL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453358 ↗
• InjuryApr 16, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, AFTER FIRING WAS PERFORMED, THE ANVIL HEAD TILTED VERTICALLY, BUT IT WAS NOT BEYOND THE ANASTOMOSED SITE AND IT COULD NOT BE REMOVED. WHEN THEY CONTINUED TO PULL IT TO REMOVE, THE ANVIL HEAD CAME OFF. THEANVIL HEAD THAT CAME OFF WAS MANUALLY PUSHED OUT FROM THE OUTSIDE AND WAS COLLECTED FROM THE ANUS. THIS RESULTED TO OOZING BLEEDING. THE MUSCLE LAYER ON THE COLON SIDE OF THE ANASTOMOSED SITE WAS TORN DUE TO THE PULLING AT THE TIME OF REMOVAL, SO THE SUTURE WAS REINFORCED CIRCUMFERENTIALLY. THE LEAK TEST WAS NEGATIVE, BUT AFTER THAT, ALL LAYERS SUTURE WERE ADDED CIRCUMFERENTIALLY TO SOLVE THE PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9970690 ↗
• MalfunctionMar 18, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING ESOPHAGUS PROCEDURE, WHEN THE SURGEON COMBINING THE ANVIL AND THE STAPLER, THEY COULD NOT BE FIXED PROPERLY AND ABNORMITY WAS FELT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850317 ↗
• MalfunctionSep 26, 2019Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING SUB TOTAL GASTRECTOMY PROCEDURE, THE SHAFT OF THE ANVIL OPENED. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 9125677 ↗
• MalfunctionDec 19, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, THE FIRST DEVICE WAS USE IN GASTROJEJUNOSTOMY AND THE SECOND DEVICE IN JEJUNOJEJUNOSTOMY. THE SURGEON FELT THAT THE HANDLE BECAME MORE STIFF THAN USUAL. IT WAS IMPOSSIBLE TO SQUEEZE THE HANDLE TO GET REACH TO THE MAIN BODY AS USUAL USE. AFTER PROCEDURE, THEY RESET THE ANVIL AND CONFIRMED THAT THE HANDLE WAS STILL VERY STIFF. A STRONG RESISTANCE WAS FELT WHEN THERE WAS AT ABOUT 1.5 CM TO COMPLETE THE SQUEEZING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8179586 ↗
• MalfunctionJun 4, 2018Bent; Bent

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, THEY OPENED THE PACKAGE OF THE DEVICE, HOWEVER THE ANVIL CENTER ROD OPENED WIDER THAN USUAL. THEY REPLACED WITH A NEW DEVICE AND THE PROCEDURE WAS CONTINUED. AFTER THE SURGERY, THE NURSE THOUGHT THAT THEY MIGHT HAVE TOUCHED THE ANVIL CENTER ROD AND BENT IT ACCIDENTALLY. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7565907 ↗
• MalfunctionMay 2, 2018Failure 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 TOTAL LAPAROSCOPIC GASTRECTOMY, WHILE BEING APPLIED ON THE ESOPHAGOJEJUNAL ANASTOMOSIS, THE INSTRUMENT'S HANDLE COULD BE FULLY SQUEEZED BUT THERE WAS A POOR STAPLE FORMATION AND BLEEDING. THEY HAD TO RESECT AND RE-STAPLE THE STAPLE LINE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 7479529 ↗
• MalfunctionApr 20, 2018Bent; Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING A LAPAROSCOPY TOTAL GASTRECTOMY PROCEDURE, WHEN THEY REMOVED THE DEVICE FROM THE PACKAGE, THEY FOUND OUT THAT THE ANVIL CENTER ROD WAS BENT TO INWARD SIDE. THEY THEN REPLACED A NEW DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7447065 ↗
• MalfunctionOct 27, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS AN UNUSUAL EFFORT REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. WHEN THE SURGEON TRIED TO ROTATE THE KNOB OF THE DEVICE, HE FELT THAT IT WAS NOT SMOOTH COMPARED TO OTHER AND USUAL CASES. SO HE CHANGED THE DEVICE TO A NEW ONE AND COULD FINISH THIS PROCEDURE WITHOUT ANY ADDITIONAL EVENT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983028 ↗