EEA HEM3348Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10884521047563), received between Jul 7, 2016 and Aug 27, 2026 — classified as 27 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (33 reports).

2 other recalls cover devices cleared under the same FDA submission (K083781); 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. 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 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Device Slipped

  According to the reporter, during a hemorrhoidectomy, while engaging the anvil with the stapler, the grip could not be secured and proper lock-in was not achieved. The surgeon was unable to tighten the knob, as it was moving freely without locking. As a result, the device could not be used, and an alternate stapling device was utilized to complete the procedure. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470317 ↗
• MalfunctionMar 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDOPEXY, THE INSTRUMENT DID NOT FIRE WHICH BOTH THE CUT AND STAPLE FUNCTIONS DID NOT OCCUR AS INTENDED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND COMPLETING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654133 ↗
• MalfunctionOct 21, 2025Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ANVIL AND SHAFT WERE NOT ENGAGING PERFECTLY. ADDITIONALLY, IT WAS NOTED THAT THE ANVIL BROKE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346974 ↗
• MalfunctionAug 28, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEMORRHOIDECTOMY, WHILE STAPLING IN THE RECTUM, THE STAPLES OF THE CIRCULAR STAPLER DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES BEING PLACED. THE DEVICE WAS REPLACED WITH ANOTHER CIRCULAR STAPLER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tissue Breakdown

  MAUDE report 22910792 ↗
• MalfunctionJul 17, 2025Break; Misfire; Mechanics Altered; Break; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDAL CASE, DURING FIRING, THE TWO STAPLERS GOT MALFUNCTIONED.

  Patient problems: Insufficient Information

  MAUDE report 22537849 ↗
• MalfunctionJul 17, 2025Break; Misfire; Mechanics Altered; Break; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO STAPLERS DID NOT PROPERLY WORK. IT WAS NOTED THAT IT WAS ALREADY DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 22537794 ↗
• MalfunctionApr 23, 2025Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR MUCOSAL HEMORRHOID PROLAPSE USING THE LONGO TECHNIQUE, THE STAPLER DID NOT PERFORM A COMPLETE RESECTION OF THE RECTAL AMPULLA MUCOSA. THE STAPLER APPEARED NOT TO HAVE EXECUTED THE CUT AND PLACEMENT OF THE SUTURES IN THE UPPER CIRCUMFERENCE AREA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896441 ↗
• MalfunctionMar 11, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, THERE WAS A POOR STAPLE FORMATION. SURGICAL TIME WAS EXTENDED BY 20 MINUTES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21576770 ↗
• MalfunctionSep 3, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE WIRES WERE MALFORMED. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY ONE AND A HALF HOURS.

  Patient problems: Tissue Breakdown

  MAUDE report 20126819 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A HEMORRHOID CASE, THE STAPLER DID NOT FIRE. THE SURGEON USED A NEW STAPLER FROM THE SAME BATCH TO COMPLETE THE CASE. NO TISSUE DAMAGE HAPPENED DURING THE INITIAL SURGERY. THE NEXT DAY, THE PATIENT HAD A BLEEDING. THE PATIENT WAS PUT ON MEDICATION TO TREAT THE BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM WHEREIN MULTIPLE STITCHES WERE MADE TO THE STAPLE LINE. BLOOD TRANSFUSION WAS NOT NEEDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19707102 ↗
• MalfunctionJul 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMORRHOID CASE, THE STAPLER DID NOT FIRE. THE SURGEON USED A NEW STAPLER FROM THE SAME BATCH TO COMPLETE THE CASE. NO TISSUE DAMAGE HAPPENED DURING THE INITIAL SURGERY. THE NEXT DAY, THE PATIENT HAD A BLEEDING. THE PATIENT WAS PUT ON MEDICATION TO TREAT THE BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM WHEREIN MULTIPLE STITCHES WERE MADE TO THE STAPLE LINE. BLOOD TRANSFUSION WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706899 ↗
• MalfunctionJun 12, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMORRHOID PROCEDURE, DURING ANVIL FIXATION, THE DEVICE DID NOT ATTACH TO THE ANVIL. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519068 ↗
• MalfunctionJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN AN OPEN STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR MINIMALLY INVASIVE PROCEDURE FOR HAEMORRHOIDS (MIPH), WHILE FIRING, TWO HEMORRHOID STAPLERS FIRED AND CUT THE TISSUE BUT THE STAPLE LINE DID NOT FORM. THE ISSUE RESULTED TO INCREASE OF BLOOD LOSS, TISSUE DAMAGE, TISSUE LOSS, AND DELAY TO PROCEDURE OF MORE THAN 30 MINUTES. THE DOCTOR HAD TO USE SUTURE SLOWLY TO OVERCOME THE BLEEDING.

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

  MAUDE report 19519053 ↗
• MalfunctionJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN AN OPEN STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR MINIMALLY INVASIVE PROCEDURE FOR HAEMORRHOIDS (MIPH), WHILE FIRING, TWO HEMORRHOID STAPLERS FIRED AND CUT THE TISSUE BUT THE STAPLE LINE DID NOT FORM. THE ISSUE RESULTED TO INCREASE OF BLOOD LOSS, TISSUE DAMAGE, TISSUE LOSS, AND DELAY TO PROCEDURE OF MORE THAN 30 MINUTES. THE DOCTOR HAD TO USE SUTURE SLOWLY TO OVERCOME THE BLEEDING.

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

  MAUDE report 19519051 ↗
• MalfunctionMay 24, 2024Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN STAPLED HEMORRHOIDOPEXY, AFTER TAKING THE PURSESTRING SUTURE, WHILE ENGAGING THE ANVIL AND STAPLER, IT DID NOT ENGAGE AND WAS FREE, SO THE SURGEON WAS NOT ABLE TO FIRE THE STAPLER. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397955 ↗
• MalfunctionApr 24, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDOPEXY PROCEDURE, THE STAPLER TORE THE TISSUE, LEADING TO SIGNIFICANT BLEEDING. THERE WERE NO ISSUES WITH HANDLING THE DEVICE, AND THERE WAS NO EXCESS TISSUE, HOWEVER, NO STAPLING OCCURRED, AND THE STAPLES REMAINED OPEN. THE SURGICAL TIME WAS EXTENDED DUE TO DEVICE ISSUE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 19172879 ↗
• MalfunctionMar 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, THE ANVIL WAS NOT FIXED PROPERLY WHEN BEING ATTACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989718 ↗
• MalfunctionJan 23, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, AT THE MIDDLE RECTUM, THERE WAS A POOR STAPLE FORMATION. OVER SUTURING AND HAND SUTURING WERE DONE ON THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 18567687 ↗
• MalfunctionDec 3, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, WHEN CUTTING AND STAPLING, THE KNIFE BLADE STILL CUT, BUT NO STAPLES WERE FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18253703 ↗
• MalfunctionOct 18, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMORRHOIDECTOMY, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958751 ↗
• MalfunctionJun 23, 2023Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN AN OPEN HEMORRHOIDECTOMY, THE HANDLE WAS FULLY SQUEEZED DURING FIRING, BUT THE SURGEON NOTICED THAT THERE WAS POOR STAPLE FORMATION. THE STAPLE LINE WAS ALSO INCOMPLETE. THE UNFORMED STAPLES FELL INTO THE PATIENT¿S CAVITY. NOT ALL FALLEN STAPLES WERE RETRIEVED. A NEW STAPLER WAS OPENED, AND A NEW CERCLAGE WAS DONE. THE STAPLE LINE WAS RESECTED AND RE-STAPLED.

  Patient problems: Failure to Anastomose; Foreign Body In Patient; Tissue Breakdown

  MAUDE report 17191658 ↗
• MalfunctionJun 13, 2023Detachment of Device or Device Component; Expulsion; Detachment of Device or Device Component; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN STAPLED HEMORRHOIDOPEXY PROCEDURE, AFTER ROTATING THE KNOB BACK UNTIL THE GREEN LINE WAS VISIBLE AND THE SECURITY LOCK WAS REMOVED, THE STAPLES WERE FALLING DOWN INTO THE ANAL CANAL WITHOUT FIRING. THE USER WAS ABLE TO RETRIEVE ALL THE FALLEN PIECES. TO RESOLVE THE ISSUE, A NEW STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119087 ↗
• MalfunctionMay 26, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN STAPLER HEMORRHOIDECTOMY, AFTER TAKING THE PURSE STRING, THE STAPLER WAS ATTACHED WITH ANVIL, BUT THE ANVIL WAS GETTING SLIPPED FROM THE INTEGRATED TROCAR. A RE-ATTEMPT WAS DONE AND THE STAPLER WAS CLOSED UNTIL GREEN BAR WAS VISIBLE. AFTER THAT, THE STAPLER WAS TRIED FOR FIRING, BUT IT DID NOT FIRE, SO ANOTHER STAPLER FROM DIFFERENT LOT WAS USED, BUT IT ALSO DID NOT FIRE. THE SURGEON THEN FINALLY USED STAPLER FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014465 ↗
• MalfunctionApr 3, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE TWO DEVICES MISFIRED WHICH LED TO A LITTLE BLEEDING. THE BLEEDING WAS CONTROLLED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16666807 ↗
• MalfunctionApr 3, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE TWO DEVICES MISFIRED WHICH LED TO A LITTLE BLEEDING. THE BLEEDING WAS CONTROLLED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16666187 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083781. One submission often covers many models, so check the product and lot details in each record.

• Z-1527-2018 · Apr 9, 2018 · Terminated
  EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: T
• Z-1528-2018 · Apr 9, 2018 · Terminated
  EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: T