EEA EEA28Recalls & reported problems

Summary

The FDA's MAUDE database contains 992 adverse event reports that list this exact device (DI 10884523005530), received between Jul 6, 2016 and Sep 21, 2026 — classified as 6 deaths, 456 injuries, 530 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (262 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 992 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  According to the reporter, intra-operatively, the air leak test was positive after firing the stapler requiring a laparoscopic suture repair and diverting stoma.

  Patient problems: Failure to Anastomose

  MAUDE report 50842647 ↗
• MalfunctionSep 21, 2026Break

  According to the reporter, during a procedure, the safety lock of the circular stapler broke. 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 50841927 ↗
• MalfunctionAug 13, 2026Failure to Form Staple

  Patient problems: Failure to Anastomose

  MAUDE report 50236580 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220833 ↗
• MalfunctionAug 6, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160982 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065786 ↗
• MalfunctionJul 14, 2026Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PARTIAL COLECTOMY, WHEN REMOVING THE DEVICE AFTER FIRING, THE ANVIL BECAME DISCONNECTED FROM THE HANDLE, AND THE SURGEON HAD TO REMOVE IT MANUALLY BY USING A CLAMP. THE ANVIL WAS BENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25809457 ↗
• MalfunctionJul 9, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION FOR RECTAL CANCER, THE INNER RING OF STAPLES DID NOT FULLY CLOSE DURING DIGESTIVE TRACT RECONSTRUCTION AND COLORECTAL ANASTOMOSIS, RESULTING IN POOR STAPLE FORMATION. MANUAL REINFORCEMENT SUTURING, RESECTION, AND RE-STAPLING WERE PERFORMED TO COMPLETE THE PROCEDURE.

  Patient problems: Tissue Breakdown

  MAUDE report 25769206 ↗
• InjuryJun 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED RECTOSIGMOIDECTOMY, DURING ANORECTAL ANASTOMOSIS, THE ANVIL DETACHED PRIOR TO STAPLING. THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY FOR REMOVAL OF THE ANVIL. THE ANVIL WAS REMOVED THROUGH THE OPENING OF THE CAVITY. THE SURGICAL TIME WAS EXTENDED BY ONE HOUR AND A NEW CIRCULAR STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Laceration(s)

  MAUDE report 25474130 ↗
• MalfunctionMay 22, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RIGHT HEMICOLECTOMY, AT THE TIME OF ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION. ADDITIONAL RESECTION AND RE-STAPLING WAS PERFORMED USING A NEW STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 25263081 ↗
• MalfunctionApr 27, 2026Misfire

  IT WAS REPORTED THAT DURING A GASTROTOMY, THE TISSUE DONUT WAS INCOMPLETE AFTER FIRING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000629 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVELY, THE PATIENT EXPERIENCED RECTAL BLEEDING AFTER USING THE TWO CIRCULAR STAPLERS WITH BLEEDING REPORTED AT THE STAPLE LINE AND AT THE ANASTOMOSIS. THE BLEEDING THEN STOPPED SPONTANEOUSLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24932061 ↗
• InjuryMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, AFTER FIRING, THE STAPLER¿S ANVIL REMAINED INSIDE THE LEFT COLON. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY TO RETRIEVE THE ANVIL FROM INSIDE THE COLON, FOLLOWED BY DISMANTLING AND REPAIR UPSTREAM AND DOWNSTREAM OF THE ANASTOMOSIS.

  Patient problems: Laceration(s)

  MAUDE report 24746478 ↗
• MalfunctionMar 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THAT THE INSTRUMENT DID NOT FIRE. THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637635 ↗
• MalfunctionMar 17, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN INCOMPLETE STAPLE LINE (PARTIALLY FIRED) OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER CIRCULAR STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24623905 ↗
• MalfunctionMar 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN LEFT HEMICOLECTOMY PROCEDURE, AT THE TIME OF DIGESTIVE TRACT RECONSTRUCTION, THE SPACE BETWEEN THE CARTRIDGE AND ANVIL WAS CLOSED, AND THE GREEN BAR WAS VISIBLE IN THE INDICATOR WINDOW, BUT THE STAPLER DID FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE STAPLER WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568036 ↗
• MalfunctionMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE, AFTER FIRING, THE STAPLE LINE WAS NOT HOLDING STEADY. THE DEVICE WAS REPLACED BY A NEW CIRCULAR STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24504252 ↗
• MalfunctionMar 2, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANASTOMOSIS INTESTINAL PROCEDURE, WHEN ATTEMPTING TO PERFORM THE ANASTOMOSIS, THE INTESTINE ONLY TORE AND DID NOT STAPLE. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT AND TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SURGICAL TIME EXTENDED FOR 30 MINUTES OR MORE.

  Patient problems: Failure to Anastomose

  MAUDE report 24484316 ↗
• MalfunctionFeb 27, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE CUT BUT THE STAPLES DID NOT DEPLOY. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24469213 ↗
• MalfunctionFeb 24, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR RECTAL CANCER INVOLVING AN END-TO-END RECTAL ANASTOMOSIS, THE DEVICE DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430830 ↗
• MalfunctionFeb 23, 2026Failure to Form Staple; Noise, Audible

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HARTMANN'S PROCEDURE REVERSAL, SOME STAPLES WERE FORMED WHILE OTHERS REMAINED UNFORMED IN THE PATIENT. IT WAS ALSO NOTED THAT THE STAPLER DID NOT SOUND NORMAL WHEN FIRED, DESCRIBING IT AS A LOUD CRACK. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY TWO HOURS DUE TO THE ANASTOMOSIS FALLING APART, WHICH WAS ATTRIBUTED TO A FAILURE OF THE STAPLE LINE. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 24424785 ↗
• MalfunctionFeb 18, 2026Misfire

  IT WAS REPORTED THAT DURING A SURGERY, THE CIRCULAR STAPLER SPONTANEOUSLY FIRED A PROJECTILE, WHICH RENDERED THE DEVICE UNUSABLE. THE DEVICE WAS REPLACED WITH NEW MATERIAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381059 ↗
• MalfunctionFeb 12, 2026Failure to Fire; Human-Device Interface Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE INSTRUMENT DID NOT FIRE, AND THERE WAS DIFFICULTY WITH THE SAFETY LEVER. THE DEVICE WAS REPLACED WITH A SIMILAR PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328794 ↗
• MalfunctionFeb 11, 2026Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE CIRCULAR STAPLER WAS APPLIED AT THE RIGHT HEMI COLON ANASTOMOSIS SITE. POOR STAPLE FORMATION WAS OBSERVED, WITH SOME STAPLES NOT PERFECTLY FORMED INTO A "B" SHAPE, INDICATING INCOMPLETE STAPLE FORMATION. SLIGHT RESISTANCE WAS FELT AT THE END OF THE HANDLE DURING USE, AND THE ANVIL COULD BE TILTED AFTER FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED AS A CORRECTIVE ACTION, AND THE STAPLER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE.

  Patient problems: Tissue Breakdown

  MAUDE report 24314591 ↗
• MalfunctionFeb 6, 2026Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, AT THE TIME OF INTESTINAL ANASTOMOSIS, WHEN THE HANDLE WAS FULLY SQUEEZED, THERE WAS A SENSATION OF STICKING, AND IT WAS LATER OBSERVED THAT SOME STAPLES WERE NOT FULLY FORMED INTO A B-SHAPE. THE STAPLE LINE WAS INCOMPLETE. TO RESOLVE THE ISSUE, RESECTION AND RE-SUTURING WAS PERFORMED. THE ISSUE LED TO UNANTICIPATED TISSUE LOSS.

  Patient problems: Failure to Anastomose

  MAUDE report 24277375 ↗