N/A NTLC55Recalls & reported problems
Ethicon Endo-Surgery, LLC · 55mm Linear Cutter for use with Selectable Reload, No cartridge Included · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon linear cutter stapler is a surgical device that cuts tissue and places staples. Many of the 182 reports describe the device failing to fire or breaking during surgery, and most report no patient consequences. The reports include 175 malfunctions, 6 injuries and 1 death. 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
- 182
- Deaths reported
- 1
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 10705036002611), received between Jan 5, 2018 and Aug 13, 2026 — classified as 1 death, 6 injuries, 175 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (60 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 Fire60
- Break33
- Firing Problem19
- Failure to Form Staple18
- Insufficient Device Problem Information13
- Device Markings/Labelling Problem11
- Detachment of Device or Device Component10
- Difficult to Open or Close6
Patient problems
- No Clinical Signs, Symptoms or Conditions110
- No Consequences Or Impact To Patient66
- Failure to Anastomose7
- Abdominal Pain2
- Hemorrhage/Blood Loss/Bleeding2
- Abdominal Distention1
- Blood Loss1
- Hematoma1
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236948 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem; Firing Problem
It was reported that post op to a Hemicolectomy there was an anastomotic leak. The anastomosis was side to side, to control the same suturing has been done.
Patient problems: Failure to Anastomose
MAUDE report 50144900 ↗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 25270506 ↗MalfunctionMar 23, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE WHILE DOING A COLECTOMY PROCEDURE, NEW NTLC55 GUN DID NOT WORK. IT WAS USED FOR THE FIRST CASE. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24666168 ↗MalfunctionMar 5, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLOSE STAPLE HEIGHT SELECTOR IS BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521496 ↗MalfunctionFeb 6, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, ONE METAL PART OF ANVIL SIDE BROCK DURING FIRING. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280650 ↗MalfunctionFeb 5, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK SURGERY, THE KNIFE FAILED TO ADVANCE BEYOND THE ONE-THIRD POSITION. THE PROCEDURE WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270424 ↗MalfunctionFeb 2, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RELOAD SELECTING KNOB BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24240709 ↗MalfunctionFeb 2, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE BOWEL RESECTION PROCEDURE, 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 24240314 ↗MalfunctionJan 12, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, COULD NOT FIRE. CHANGED TO 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 24043454 ↗MalfunctionDec 10, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRING KNOB WAS STIFF, SO IT 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 23772286 ↗MalfunctionNov 13, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE NTLC55 WAS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541701 ↗MalfunctionOct 2, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE PINS WERE MISFORMED AND THERE WAS A LEAK NOTICED ON THE TISSUE.THE PROCEDURE WAS SUCCESSFULLY COMPLETED.THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions
MAUDE report 23199172 ↗MalfunctionAug 4, 2025Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, THE FIRING KNOB FELL OFF. 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 22704309 ↗MalfunctionJul 23, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE HAS FIRING ISSUES. HE CHANGED THE NEW GUN AND COMPLETED THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574547 ↗MalfunctionJul 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT WORK. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574452 ↗MalfunctionJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22511556 ↗MalfunctionJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TRANSECTION WAS NOT SO SMOOTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382964 ↗MalfunctionJun 27, 2025Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FIRING KNOB WAS TOO TIGHT TO FIRE. TRANSECTION WAS NOT SO SMOOTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344731 ↗MalfunctionMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. AWB (B)(4) RECEIVED 2/10/2025. BOX MARKED AS (B)(4) ON AWB (B)(4); RECD NTLC55; LOT# 151C58; ECM HAS NTLC75; FROM COUNTRY INDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047124 ↗MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, NOTED THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027285 ↗MalfunctionApr 21, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY THE DEVICE DID NOT FIRE DURING THE CASE AND IT GOT STRUCK .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874111 ↗MalfunctionApr 7, 2025Firing Problem; Firing Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE DURING FIRING SURGEON FOUND THE FIRING KNOB WAS DAMAGED, HE CHANGED THE GUN AND COMPLETED THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21785440 ↗MalfunctionMar 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION. ATTEMPTS WERE MADE TO RECONCILE THE DEVICE WITH NO SUCCESS RESULTING IN THE CREATION OF A NEW COMPLAINT. AWB 282277633033 RECEIVED 12/04/2024. BOX MARKED AS (B)(4) ON AWB 282277633033; RECD NTLC55; LOT# 362C95; ECM HAS NTLC75; LOT# 508C77 FROM COUNTRY INDIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676545 ↗MalfunctionMar 19, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER SLIDER DID NOT MOVE AFTER LOADING. TO PROCEDURE COMPLETED PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE. NO CONSEQUENCES FOR THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21642851 ↗
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- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
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- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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