N/A NTLC75Recalls & reported problems
Ethicon Endo-Surgery, LLC · 75mm Linear Cutter for use with Selectable Reload, No cartridge Included · Class 2
Quick summary
This Ethicon 75mm linear cutter is a surgical stapler that cuts and staples tissue during operations. Of its 1,139 reports, 9 describe a patient death, 91 describe injuries and 1,039 describe malfunctions. Many reports describe the stapler not firing, its firing knob sticking, parts breaking, and staples not forming, and in several reports another device finished the procedure. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,140
- Deaths reported
- 9
- Injuries reported
- 91
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,140 adverse event reports that list this exact device (DI 10705036002628), received between Jul 20, 2015 and Sep 30, 2026 — classified as 9 deaths, 91 injuries, 1,040 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (339 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire339
- Break269
- Failure to Form Staple198
- Firing Problem81
- Detachment of Device or Device Component75
- Mechanical Jam61
- Adverse Event Without Identified Device or Use Problem54
- Difficult to Open or Close44
Patient problems
- No Consequences Or Impact To Patient530
- No Clinical Signs, Symptoms or Conditions520
- Failure to Anastomose60
- No Code Available33
- Fistula12
- Hemorrhage/Blood Loss/Bleeding12
- Unspecified Tissue Injury12
- Insufficient Information9
Recent adverse event reports
The 25 most recent of 1,140 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Form Staple; Failure to Fire
It was reported that during a Right Hemicolectomy procedure after fired, noted the staples malformed and then 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 50946329 ↗MalfunctionSep 24, 2026Appropriate Device Problem Term/Code Not Available
It was reported that during an Unknown procedure the selectable Height Is Broken.Was there any reported patient or user harm? Unknown. Was there a significant delay? Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882961 ↗MalfunctionSep 17, 2026Failure to Fire; Mechanical Jam
It was reported that during an Unknown procedure the Surgeon noticed there is misalignment of the left and right side anvil. After attached together, the blade was seen exposed in between firing handle and the knife couldn¿t advance for firing. Was there any reported patient or user harm? No. Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801643 ↗MalfunctionSep 17, 2026Failure to Fire; Mechanical Jam
It was reported that during an Unknown procedure the Surgeon noticed there is misalignment of the left and right side anvil. After attached together, the blade was seen exposed in between firing handle and the knife couldn¿t advance for firing. Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801641 ↗MalfunctionAug 31, 2026Failure to Fire
It was reported that during an unknown surgery ,the device could not be fired. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524599 ↗MalfunctionAug 31, 2026Mechanical Jam
It was reported that, during an unknown surgery, the first firing was completed without issue. However, during the second firing, the firing knob did not move. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50524210 ↗MalfunctionAug 24, 2026Failure to Fire
It was reported that, during a pancreaticoduodenectomy, the device could be used without issues at the first firing during the initial duodenal transection, but the firing knob became stiff and did not move at the second firing during the gastric body transection. The doctor tried to advance the knife several times, but it did not move and the knife did not reach the stomach body. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50407418 ↗MalfunctionAug 14, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253030 ↗MalfunctionAug 11, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213330 ↗MalfunctionAug 11, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213081 ↗MalfunctionAug 11, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207533 ↗MalfunctionAug 10, 2026Failure to Fire
It was reported that during an Unknown procedure the Scrub nurse properly loaded the cartridge to the body upon ODP guide, but the surgeon was unable to fire the New TLC stapler all the way in order to transect the tissue. Was surgery delayed due to the reported event? No. Was procedure successfully completed? Unknown. Were fragments generated? Unknown. If yes, were they removed easily without additional intervention? Unknown. Patient Status/ Outcome / consequences No. Was other medical intervention (e.g. X-rays, additional procedures, prescriptions, OTC, revision) required: Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50197280 ↗MalfunctionJul 8, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748633 ↗MalfunctionJul 1, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE OPEN RIGHT HEMICOLECTOMY 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 25680561 ↗MalfunctionJun 8, 2026Failure to Fire
IT WAS REPORTED THAT, DURING OPEN BOWEL OBSTRUCTION SURGERY, WHEN FIRING WAS ATTEMPTED, THE KNIFE MOVED FORWARD SLIGHTLY BUT DID NOT MOVE FORWARD FURTHER AFTER THAT. THE DOCTOR, ATTEMPTED TO FIRE, BUT THE KNIFE DEVICE DID NOT OPERATE AT ALL. THE DEVICE WAS REPLACED WITH ECHELON TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436863 ↗MalfunctionJun 4, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNK PROCEDURE, THE DEVICE DID NOT FIRE WHILE STAPLING. AS A RESULT, THE SURGEON HAD TO USE A NEW STAPLER TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399385 ↗MalfunctionMay 29, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN INTESTINAL OCCLUSION SURGERY DEVICE NTLC75 PRESENTS FAILURE DURING SURGERY, DOES NOT ALLOW TO ADVANCE BLADE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334264 ↗MalfunctionMay 25, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS NOT WORKING. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270487 ↗MalfunctionMay 25, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UPON PLACING THE NTLC75 AND SR75 ON THE BOWEL, THE SURGEON ENCOUNTERED DIFFICULTY FIRING THE DEVICE AND THE DEVICE COULD NOT BE FIRED. A NEW RELOAD WAS OPENED AND RELOADED TO THE NTLC75 AND THE TRANSECTION OF THE BOWEL THEN COULD BE COMPLETED WITHOUT ANY ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270432 ↗MalfunctionMay 14, 2026Material Integrity Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, ANVIL WAS DISLODGE AND SELECTOR WAS NOT WORKING. NO PATIENT CONSEQUENCES WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176269 ↗MalfunctionMay 12, 2026Failure to Fire
IT WAS REPORTED THAT DURING UNK PROCEDURE, 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 25154444 ↗MalfunctionMay 4, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER STAPLING, THE GUILLOTINE DID NOT WORK CORRECTLY IN A FIRST UNIT. A SECOND NEW UNIT OF THE SAME PRODUCT WAS USED, PRESENTING EXACTLY THE SAME INCIDENT. DUE TO THIS SITUATION, THE SURGEON WAS FORCED TO RESORT TO A LAPAROSCOPIC ENDOCUTTERIN ORDER TO FINISH THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071762 ↗MalfunctionMay 4, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS JAMMED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071676 ↗MalfunctionApr 24, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION, ACCORDING TO SURGEON STAPLES DID NOT FORM AT ALL WHEN FIRING OVER BOWEL. ALL STAPLES WERE OPEN AND DID NOT CLOSE. THERE WAS NO SURGICAL DELAY AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984066 ↗MalfunctionApr 23, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, NTLC75 WAS NOT WORKING. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965718 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.