N/A SR55Recalls & reported problems
Ethicon Endo-Surgery, LLC · Linear Cutter Reloads, 55mm Selectable -6 Rows · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is an Ethicon SR55 linear cutter reload, a disposable stapling cartridge used in surgery. The 67 reports mostly describe the stapler failing to fire or staples not deploying, and in some cases the cartridge jamming; in the reports that describe surgery, the device was swapped out to finish the operation and no lasting harm to the patient was mentioned. No deaths or injuries are reported. There are no recalls naming 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 10705036002826), received between Jan 29, 2018 and Sep 24, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (42 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 Fire42
- Failure to Form Staple23
- Device Markings/Labelling Problem3
- Mechanical Jam3
- Firing Problem2
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient15
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883986 ↗MalfunctionSep 24, 2026Failure to Fire
It was reported that during an Unknown procedure the cartridge blade not coming out.Are there any reported cases of harm from patients or users? Unknown.Was there a significant delay? Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883938 ↗MalfunctionJun 29, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UNIVERSAL RELOAD COULDN'T FIRE PROPERLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651265 ↗MalfunctionJun 4, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, STAPLES DID NOT DEPLOY UPON FIRING. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399942 ↗MalfunctionMay 29, 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 25334526 ↗MalfunctionMar 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, COULD NOT FIRE. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592706 ↗MalfunctionMar 5, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CARTRIDGE MISFIRED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521547 ↗MalfunctionFeb 26, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. CHANGED TO A 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 24456291 ↗MalfunctionFeb 20, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNK 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 24401428 ↗MalfunctionJan 20, 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 24120896 ↗MalfunctionJan 13, 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 24059045 ↗MalfunctionDec 2, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT BEFORE AND UNK PROCEDURE THAT THE KNIVES WERE EXTENDED AND VISIBLE ON THE MAGAZINES. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693785 ↗MalfunctionDec 2, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT BEFORE AND UNK PROCEDURE THAT THE KNIVES WERE EXTENDED AND VISIBLE ON THE MAGAZINES. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693765 ↗MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN 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 23522120 ↗MalfunctionOct 31, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT THE RELOAD DID NOT FIRE PROPERLY. NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441907 ↗MalfunctionApr 28, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN ANASTOMOSIS THE STAPLER RELOAD GOT MISFIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917976 ↗MalfunctionApr 21, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A GASTRECTOMY THE DEVICE DID NOT FIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872236 ↗MalfunctionFeb 26, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A GASTRECTOMY THE DEVICE MISFIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468732 ↗MalfunctionFeb 18, 2025Failure to Fire; Firing Problem; Failure to Fire; Firing Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400963 ↗MalfunctionFeb 3, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A PROCTOCOLECTOMY 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 21291573 ↗MalfunctionOct 28, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE SOME OF THE STAPLES ON THE CARTRIDGE WERE PROTRUDING. THERE WAS NO PATIENT CONSEQUENCES IDENTIFIED WHEN THIS COMPLAINT EVENT WAS CAPTURED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20548457 ↗MalfunctionJul 17, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE THE RELOAD DID NOT FIRED. NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19766177 ↗MalfunctionJun 22, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR RIGHT COLON CANCER SURGERY, THE DEVICE 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 19590928 ↗MalfunctionJun 21, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD MISFIRED. THERE WAS A 15 MINUTE SURGICAL DELAY. ANOTHER RELOAD USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582848 ↗MalfunctionJun 12, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CARTRIDGE HAS NO PINS DURING FIRING, MISFIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519677 ↗
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- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- 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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