N/A SR75Recalls & reported problems

Summary

The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 10705036002833), received between Dec 15, 2017 and Sep 30, 2026 — classified as 3 deaths, 8 injuries, 428 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (164 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 439 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut

  It was reported during a Bowel procedure, after fired and removed the device, noted that the suture was not cut . There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946227 ↗
• MalfunctionSep 30, 2026Failure to Fire

  It was reported that during an Unknown surgery, could not fire. Changed the new one to complete surgery. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946140 ↗
• MalfunctionSep 1, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544075 ↗
• MalfunctionAug 27, 2026Failure to Cut; Failure to Fire

  It was reported that during a Cystectomy when NTLC75 with its SR75 reload was fired into the intestine, it triggered the staples of half of the reload and the other half only cut (not stapled). Photographs are attached. Was there any harm to the reported patient or user? No. Was there a significant delay? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475577 ↗
• MalfunctionAug 24, 2026Failure to Fire

  It was reported that during an Unknown colon surgery a (b)(6) stapler is used for colon segment resection with refill and works normally, at the time of the second new refill the stapler does not staple or pass a blade.Was there any harm to the reported patient or user? No. Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50406215 ↗
• MalfunctionAug 13, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236073 ↗
• MalfunctionAug 13, 2026Failure to Fire; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235766 ↗
• MalfunctionAug 13, 2026Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235561 ↗
• MalfunctionAug 11, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209978 ↗
• MalfunctionAug 11, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209977 ↗
• DeathJul 31, 2026Failure to Form Staple

  It was reported that during or after an unknown procedure the whole staple line opened up. Patient death due to sepsis.

  Patient problems: Sepsis

  MAUDE report 50098248 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an unknown procedure there was an Anastomotic leak at staple line. The patient had an infection and extended patient stay at hospital.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 50098138 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an unknown re-exploration there was leakage from the staple line. The patient had an infection and prolong hospital stay.

  Patient problems: Failure to Anastomose; Unspecified Infection

  MAUDE report 50098051 ↗
• MalfunctionJul 27, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012297 ↗
• MalfunctionJul 20, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25875580 ↗
• MalfunctionJul 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE GASTRECTOMY SURGERY, COULD NOT FIRE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718757 ↗
• MalfunctionJul 2, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, 3 SR75 CARTRIDGES WERE NOT WORKING. ALL 3 WERE OF THE SAME BATCH. NO PATIENT CONSEQUENCES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690572 ↗
• MalfunctionJul 1, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679564 ↗
• MalfunctionJun 11, 2026Structural Problem

  IT WAS REPORTED THAT DURING THE COLECTOMY PROCEDURE, THE CARTRIDGE OF THE NTLC75 STAPLER EXPERIENCED A TECHNICAL FAILURE: WHEN IT WAS INSERTED INTO THE STAPLER IT APPEARED TO HAVE ALREADY BEEN FIRED, LIFTING THE STAPLES WITHOUT BEING PROPERLY SEATED. THE DEFECTIVE CARTRIDGE WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT HARM OR RISK TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25475630 ↗
• MalfunctionJun 8, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROTOMY FOR SMALL-BOWEL RESECTION IN THE SETTING OF MESENTERIC ISCHEMIA. WHILE USING A VIOLET 60 MM ENDOGIA STAPLER (LOT NUMBER UNKNOWN) TO RESECT THE LAST 20 CM OF SMALL INTESTINE, THE STAPLER CARTRIDGES FAILED TO FIRE ON THREE OCCASIONS. THIS CAUSED A DELAY TO THE SURGICAL PROCEDURE AND POSED A RISK OF HEMORRHAGE. A DIFFERENT LOT WAS USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436960 ↗
• MalfunctionJun 8, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROTOMY FOR SMALL-BOWEL RESECTION IN THE SETTING OF MESENTERIC ISCHEMIA. WHILE USING A VIOLET 60 MM ENDOGIA STAPLER (LOT NUMBER UNKNOWN) TO RESECT THE LAST 20 CM OF SMALL INTESTINE, THE STAPLER CARTRIDGES FAILED TO FIRE ON THREE OCCASIONS. THIS CAUSED A DELAY TO THE SURGICAL PROCEDURE AND POSED A RISK OF HEMORRHAGE. A DIFFERENT LOT WAS USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436782 ↗
• MalfunctionJun 8, 2026Structural Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, YELLOW ANVIL DRIVER WAS ALREADY PUSHED DOWN THEREFORE COULD NOT USE ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436397 ↗
• MalfunctionMay 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PROCTRECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176324 ↗
• MalfunctionMay 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176301 ↗
• MalfunctionMay 14, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, SR75 RELOAD COULDN'T FIRE PROPERLY. NO INCIDENCE OF INFECTION OR INFLAMMATION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175150 ↗