EEA EEA2535Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10884523004748), received between May 31, 2016 and Sep 23, 2026 — classified as 41 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (31 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 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Form Staple

  It was reported that, after successful firing of the single-use stapler during an implant procedure, the staple line was incomplete and did not bite properly. A new device was used to resolve the issue.

  Patient problems: Failure to Anastomose

  MAUDE report 50863491 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SAFETY LEVER BROKE WHILE STAPLING ON THE TWO INSTRUMENTS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942908 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SAFETY LEVER BROKE WHILE STAPLING ON THE TWO INSTRUMENTS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942815 ↗
• MalfunctionMar 26, 2026Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SIGMOIDECTOMY, WHEN REMOVING FROM THE PACKAGE, PART OF THE ANVIL WAS DAMAGED. 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 24706281 ↗
• MalfunctionJan 7, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, IN COLON TRANSVERSE ANASTOMOSIS, NO STAPLES WERE DEPLOYED WHEN THE DEVICE FIRED. TO RESOLVE THE ISSUE, A NEW CIRCULAR STAPLER OF THE SAME TYPE WAS USED FOR RESECTION AND RE-STAPLING.

  Patient problems: Failure to Anastomose

  MAUDE report 23996346 ↗
• MalfunctionAug 1, 2025Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE OPEN RIGHT HEMICOLECTOMY, WHEN USING THE LINEAR STAPLER TO DETACH THE RIGHT COLON, EXCESSIVE RESISTANCE WAS ENCOUNTERED, MAKING FIRING IMPOSSIBLE. THE FIRING PROCEEDED NORMALLY AFTER REPLACING IT WITH A NEW LINEAR STAPLER. SUBSEQUENTLY, WHEN USING A BRAND-NEW CIRCULAR STAPLER TO ANASTOMOSE THE TRANSVERSE COLON AND ILEUM, "B" SHAPED MALFORMED STAPLES WERE OBSERVED. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. SUTURES WERE THEN USED FOR REINFORCEMENT AFTERWARDS.

  Patient problems: Failure to Anastomose

  MAUDE report 22693091 ↗
• MalfunctionJun 17, 2025Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y PROCEDURE, THE DEVICE WAS BEING APPLIED AT THE ANASTOMOSIS WHEN THE INSTRUMENT BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233659 ↗
• InjuryDec 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY, IN ESOPHAGEAL JEJUNUM ANASTOMOTIC, THE METAL PART OF THE ANVIL HEAD WAS BROKEN, AND A METAL PIECE WAS ADHERED TO THE INTESTINAL TRACT. THE PIECE WAS REMOVED BY HAND AND CHECKED; IT FITTED PERFECTLY WITH THE DAMAGED AREA, FURTHER CHECKED WITH X-RAY, AND CONFIRMED THAT THERE WAS NO REMAINING IN THE BODY. THE ANASTOMOTIC SITE WAS REINFORCED, AND LIGATION WAS PERFORMED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR LESS THAN 30 MINUTES.

  Patient problems: Failure to Anastomose; Unintended Radiation Exposure

  MAUDE report 20873842 ↗
• MalfunctionNov 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE THORACOSCOPIC ESOPHAGEAL MALIGNANT TUMOR SURGERY, WHEN ON ESOPHAGEAL ANASTOMOSIS (ESOPHAGOJEJUNOSTOMY), IT WAS FOUND THAT SOME PARTS OF THE ANVIL APPEARED TO HAVE BEEN DAMAGED. TREATMENT INTERVENTION WAS NOT PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757847 ↗
• MalfunctionOct 8, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING AN ENDOSCOPIC SURGERY DUE TO STOMACH TUMOR, WHEN FITTING THE DEVICE WITH THE ANVIL, IT DID NOT FIT. A NEW DEVICE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396239 ↗
• MalfunctionSep 6, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DONUT WAS INCOMPLETE. SUTURING WAS DONE AS A STAPLE LINE REINFORCEMENT.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 20163263 ↗
• MalfunctionJul 23, 2024Failure 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 AN ESOPHAGUS-JEJUNAL ANASTOMOSIS, AFTER STAPLING, THE STAPLER DID NOT STAPLE ALL THE LAYERS OF THE ESOPHAGUS TO THE JEJUNUM. IT WAS NOTED THAT THE FABRIC DID NOT GET CAUGHT IN THE STAPLER, AND THE STAPLE LOOSENED EASILY. THE MOST SUPERFICIAL LAYER OF THE ESOPHAGUS WAS LEFT LOOSE IN THE ANASTOMOSIS. THE ISSUE WAS RESOLVED BY A REINFORCEMENT SUTURE IN THE ENTIRE ANASTOMOSIS. THE SURGICAL TIME WAS EXTENDED FOR THIRTY MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 19813270 ↗
• InjuryJul 23, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS AFTER COLECTOMY FOR SIGMOID RESECTION, THE STAPLES WAS NOT FORMED AT ALL SO THE ANASTOMOSIS COULD NOT BE DONE. THE COLON WAS RESECTED AND RE-ANASTOMOSIS WAS PERFORMED. SURGERY TIME WAS EXTENDED BY 30 MINUTES. ADDITIONAL REMOVAL WAS PERFORMED AND ADDITIONAL SUTURES WERE PERFORMED USING A STAPLER.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19805549 ↗
• MalfunctionJul 11, 2024Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY, WHEN USING THE OPEN STAPLER TO DETACH THE RIGHT COLON, THE RESISTANCE WAS TOO GREAT AND THE STAPLER COULD NOT BE FIRED. AFTER REPLACING IT WITH THE NEW STAPLER, IT FIRED NORMALLY. WHEN USING THE CIRCULAR STAPLER TO ANASTOMOSE THE TRANSVERSE COLON AND ILEUM, IT WAS OBSERVED THAT THERE WAS POOR FORMATION OF THE STAPLES. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. THE THREAD WAS USED TO OVER SEW THE STAPLE LINE TO FIX THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 19722736 ↗
• MalfunctionMay 24, 2024Loss of or Failure to Bond; Product Quality Problem; Detachment of Device or Device Component; Material Twisted/Bent; Loss of or Failure to Bond; Product Quality Problem; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHILE PERFORMING THE ANASTOMOSIS POUCH WITH THE INTESTINE, THE ANVIL LEGS BENT, MAKING IT DIFFICULT OR IMPOSSIBLE TO CLOSE. THE TILT-TOP ANVIL DISCONNECTED FROM THE TROCAR DURING THE STAPLER CLOSURE. IT WAS NOTICED THAT THE TILT-TOP ANVIL WAS LARGER THAN THE SAME SIZE IN ANOTHER STAPLER. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 19391407 ↗
• MalfunctionMay 16, 2024Break; Failure to Form Staple; Mechanics Altered; Break; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE ANTERIOR RESECTION OF THE RECTUM AND COLOSTOMY, THE STAPLER DID NOT STAPLE BUT IT DID CUT THE TISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19332766 ↗
• MalfunctionMar 8, 2024Failure to Fire; Failure to Fire

  ACCORDI1NG TO THE REPORTER, PRIOR TO USE, THE STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18863944 ↗
• MalfunctionFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE CALLED RECTAL SIGMOIDECTOMY, THE SURGEON FIRED THE CIRCULAR STAPLER AND PERFORMED A LEAK TEST, AND BUBBLES WERE PRESENT. THE SURGEON OVERSEWED THE STAPLE LINE AND PERFORMED A LEAK TEST, AND NO BUBBLES WERE OBSERVED. IT WAS NOTED THAT THE SURGEON WERE LEANING TOWARDS DIVERTING THE PATIENT TO A COLOSTOMY PRIOR TO THE CIRCULAR STAPLER FIRING. THE FAILED LEAK TEST AFTER THE CIRCULAR STAPLER FIRING WAS THE DECIDING FACTOR THAT ULTIMATELY LEAD THEM TO CHOOSING TO DO THE COLOSTOMY.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 18797728 ↗
• MalfunctionDec 22, 2023Difficult to Remove; Misfire; Failure to Form Staple; Difficult to Remove; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, WHILE DETACHING THE RIGHT HEMICOLON, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON DUE TO THE RESISTANCE BEING TOO HIGH. THE RIGHT HEMICOLON WAS THEN SUCCESSFULLY DETACHED USING THE SAME RELOAD AND A NEW HANDLE. WHILE ANASTOMOSING THE TRANSVERSE COLON-RIGHT HEMICOLON USING A CIRCULAR STAPLER, THE B-FORMATION OF THE STAPLES WERE POOR, THE DONUTS WERE NOT COMPLETE, AND THE ANVIL DID NOT TILT AFTER FIRING. IT WAS ALSO NOTED THAT EXCESSIVE TISSUE INCORPORATED INTO THE BARREL OF THE STAPLER. THE SURGEON SUTURED THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 18385146 ↗
• MalfunctionNov 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, OPERATOR SAID THAT BODY AND LOADING UNIT COULD NOT BE ASSEMBLED. A NEW ADDITIONAL LOADING UNIT WAS LOADED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211950 ↗
• MalfunctionOct 20, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY, WHILE CONNECTING THE ANVIL TO THE STAPLER FOR ANASTOMOSIS, THE ORANGE SIGN WAS VISIBLE BEFORE CONNECTING BUT THERE WAS NO CLICK SOUND. THE DEVICE DID NOT CONNECT. THE PROCEDURE TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. TO RESOLVE THE ISSUE, THE SURGEON HAD TO REMOVE THE FIRST STITCHED ANVIL FROM OESOPHAGUS AND STICH A SECOND ANVIL FOR THE NEW CIRCULAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978018 ↗
• MalfunctionOct 17, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SUBTOTAL GASTRECTOMY, OPEN PROCEDURE, WHEN GASTROJEJUNAL ANASTOMOSIS WAS DONE WITH THE CIRCULAR STAPLER, THE ANVIL AND STAPLER WAS JOINED AND TRIED TO FIRE, THE STAPLER FIRING WAS DONE BUT THE DONUT WAS INCOMPLETE. THE DOCTOR DID AN ADDITIONAL SUTURING NEAR THE ANASTOMOSIS TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 17951185 ↗
• MalfunctionSep 18, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, THE SURGEON NOTED DIFFICULTY IN SQUEEZING THE HANDLE OF THE STAPLER TO ANASTOMOSE ILEUM AND TRANSVERSE COLON, WHEREIN THE USER NOTED THAT THE SMALL INTESTINE WAS SWOLLEN AT THE ANVIL SIDE. AFTER FIRING THE DEVICE, THE TISSUE WAS NOT ANASTOMOSED AS THERE WAS POOR STAPLE FORMATION. ADDITIONAL RESECTION WAS PERFORMED. RE-ANASTOMOSIS WAS PERFORMED WITH ANOTHER CIRCULAR STAPLER. THE SURGEON STILL DID NOT FEEL THE ANASTOMOSIS WAS SECURE, THEREFORE ADDITIONAL SUTURING WAS PERFORMED IN WHOLE CIRCUMFERENCE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 17768304 ↗
• MalfunctionSep 13, 2023Failure to Form Staple; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Firing Problem; Failure to Form Staple; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Firing Problem

  ACCORDING TO THE REPORTER, IN A LAPAROTOMY, DURING ANASTOMOSIS, AFTER FIRING THE DEVICE, THE TISSUE WAS NOT ANASTOMOSED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 17736890 ↗
• MalfunctionJul 19, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A ROUX-EN-Y GASTRIC BYPASS, DURING ANASTOMOSIS, THE STAPLER CUT BUT DID NOT STAPLE THE TISSUE. 5-10CM (CENTIMETERS) FROM THE SMALL INTESTINE WAS CUT. THE DAMAGED AREA WAS REMOVED. THE SMALL INTESTINE AND STOMACH ANASTOMOSIS WAS REDONE WITH A NEW CIRCULAR STAPLER. ONE UNIT OF ERYTHROCYTE SUSPENSION WAS NOTED AND BLOOD WAS NOT GIVEN BECAUSE HEMODYNAMIC PARAMETERS WERE STABLE. THE BLEEDING WAS STOPPED WITH THE USE OF STITCHES AND CAUTERY. THE SURGICAL TIME WAS EXTENDED BY AT LEAST ONE HOUR DUE TO THE ISSUE.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 17356581 ↗