EEA HEM3335Recalls & reported problems

Summary

The FDA's MAUDE database contains 247 adverse event reports that list this exact device (DI 10884521047518), received between Aug 2, 2016 and Sep 15, 2026 — classified as 89 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (92 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 247 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Misfire

  It was reported that during a hemorrhoidectomy, the hemorrhoid stapler had firing issues, including a staple line incomplete and a staple formation issue. The staples were not raised, making stapling impossible. A second stapler was used however, an improper formation of the donut was observed; it appeared inconsistent and was accompanied by bleeding in the stapled area. The device was replaced with another hemorrhoid stapler.

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

  MAUDE report 50766495 ↗
• MalfunctionAug 27, 2026Failure to Cut

  It was reported that during hemorrhoidectomy, the hemorrhoid stapler fired staples but did not cut at all. The device was replaced with another device to continue the surgery. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50480755 ↗
• MalfunctionMar 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY GRADE FOUR BY LONGO TECHNIQUE, DURING USE OF THE HEMORRHOID STAPLER, AN INCOMPLETE STAPLE LINE (PARTIALLY FIRED) OCCURRED. THE DEVICE WAS REPLACED WITH A NEW ONE.

  Patient problems: Tissue Breakdown

  MAUDE report 24522007 ↗
• MalfunctionMar 3, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER FIRING THE STAPLER, THE STAPLE LINE WAS NOT FULLY FORMED. THIS RESULTED IN NEED FOR MANUAL SUTURING AS A STAPLE LINE REINFORCEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 24497855 ↗
• MalfunctionJan 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE, THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY, BUT THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER STAPLER.

  Patient problems: Insufficient Information

  MAUDE report 24028018 ↗
• MalfunctionDec 15, 2025Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A PROCEDURE FOR THE TREATMENT OF HEMORRHOIDS, THE DEVICE FAILED TO PROPERLY PLACE STAPLES, RESULTING IN A SIGNIFICANT SECTION OF THE RECTAL MUCOSA BEING CUT. THE ISSUE CAUSED SUBSTANTIAL RECTAL BLEEDING, SPECIFICALLY IN ABOUT 2/3 TO 3/4 OF THE CIRCUMFERENCE OF THE MUCOSAL AREA. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING BY SUTURING THE MUCOSAL EDGES AND PERFORMING TARGETED HEMOSTASIS OVER THE BLEEDING SECTION.

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

  MAUDE report 23803967 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732127 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729401 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728563 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728529 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728505 ↗
• MalfunctionDec 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, FOURTEEN DEVICES DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728393 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE FOR PROLAPSED HEMORRHOIDS, THE INSTRUMENT DID NOT FIRE. THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692707 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOID SURGICAL PROCEDURE, ON TWO DEVICES, THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY, AND SIZERS WERE USED. HOWEVER, THE INSTRUMENT DID NOT FIRE, WHICH RESULTED IN EXTENDED SURGICAL TIME. THE DEVICE WAS REPLACED BY CHANGING TO ANOTHER BRAND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541077 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOID SURGICAL PROCEDURE, ON TWO DEVICES, THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY, AND SIZERS WERE USED. HOWEVER, THE INSTRUMENT DID NOT FIRE, WHICH RESULTED IN EXTENDED SURGICAL TIME. THEDEVICE WAS REPLACED BY CHANGING TO ANOTHER BRAND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541072 ↗
• MalfunctionJul 8, 2025Failure to Form Staple; Human-Device Interface Problem; Noise, Audible; Failure to Form Staple; Human-Device Interface Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE HEMORRHOID STAPLER, THERE WAS A LOUD CRUSHING SOUND UPON FIRING, AS IF SOMETHING BROKE. WHEN THE ANVIL WAS OPENED, ONLY A PARTIAL STAPLE LINE WAS FORMED WHILE THE REST OF THE STAPLE LINE WAS ABSENT. BLEEDING OCCURRED. THE ANVIL WAS NOTED TO BE EASIER TO DETACH FROM THE STAPLER HANDLE COMPARED TO NORMAL TIMES. SUTURING OF THE STAPLE LINE WAS PERFORMED TO STOP THE BLEEDING AS A REPLACEMENT FOR THE STAPLE LINE.

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

  MAUDE report 22449840 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ANVIL BROKE AND DISENGAGED. 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 21368088 ↗
• MalfunctionJan 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOID PROCEDURE, THE HEMORRHOID STAPLER FAILED TO FIRE. THE HANDLE WAS FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY, AND SIZERS WERE USED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158225 ↗
• MalfunctionJan 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY INVOLVING THE HEM3335 33MM HEMORRHOID STAPLER, THE INSTRUMENT DID NOT FIRE. THIS RESULTED IN AN EXTENDED SURGICAL TIME OF 30 MINUTES. THE DEVICE WAS REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139169 ↗
• MalfunctionDec 5, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LONGO PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. THE SURGICAL TIME WAS EXTENDED FOR ONE HOUR AS A RESULT. ANOTHER HEMORRHOID STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 20853507 ↗
• MalfunctionNov 12, 2024Misfire; Failure to Form Staple; Detachment of Device or Device Component; Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER CONNECTING THE ANVIL TO THE DEVICE, THE DOCTOR CLOSED THE DEVICE AND STARTED TO FIRE, BUT THE ANVIL BREAK OUT OF THE DEVICE. THE FIRING COULD NOT BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 20669848 ↗
• MalfunctionNov 8, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A HEMORRHOID PROCEDURE, WHILE FIRING THE DEVICE, THERE WAS AN INCOMPLETE STAPLE LINE (PARTIALLY FIRED). TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 20641825 ↗
• MalfunctionSep 26, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER TYING THE PURSE STRING SUTURE AROUND THE ANVIL, CONNECTING IT TO THE MAIN STAPLER, AND AFTER CLOSING IT, IT WAS SUDDENLY DISCONNECTED FROM THE ANVIL. UNFORTUNATELY, THE SURGEON DID NOT REALIZE WHAT HAPPENED AND FIRED IT. THE STAPLES FELL AROUND. SOME MUCOSAL GAPS RESULTED FROM CUTTING WITHOUT STAPLING IN THE FIRST FAULTY STAPLER OPERATION, THE SURGEON MANAGED TO SUTURE MANUALLY AT THE END. THE STAPLES DID NOT MAKE A B-SHAPE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20311202 ↗
• MalfunctionSep 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PELVIC LYMPHADENECTOMY, THE STAPLER WAS PROPERLY CONNECTED TO ITS WARHEAD WITH ALL AUDITORY, SOUND AND TACTILE SIGNALS BUT IT DID NOT FIRE. ANOTHER STAPLER WHICH WORKED NORMALLY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297484 ↗
• MalfunctionAug 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. A NEW STAPLER WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 20044907 ↗

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