PROXIMATE TCR75Recalls & reported problems
Ethicon Endo-Surgery, LLC · PROXIMATE Linear Cutter Reload, Blue, 75mm · Class 2 · Implant
Quick summary
This Ethicon Proximate TCR75 is a reload that cuts and staples tissue during surgery. Its 142 reports often describe staples that failed to form or fire, sometimes forcing a second reload to finish the operation. There are no deaths and 8 injuries. No recalls name this device. Reports fell to 9 in the last 12 months from 18 before.
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
- 142
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10705036013136), received between Dec 5, 2017 and Jun 18, 2026 — classified as 8 injuries, 134 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (56 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 Form Staple56
- Failure to Fire45
- Adverse Event Without Identified Device or Use Problem7
- Appropriate Device Problem Term/Code Not Available7
- Material Integrity Problem6
- Firing Problem5
- Break4
- Difficult to Insert4
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- No Consequences Or Impact To Patient38
- Failure to Anastomose4
- Hemorrhage/Blood Loss/Bleeding4
- No Code Available2
- Diarrhea1
- Fever1
- Fistula1
Recent adverse event reports
The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING GASTRECTOMY PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553290 ↗MalfunctionJun 15, 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. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503848 ↗MalfunctionJun 15, 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. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503798 ↗MalfunctionMar 5, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNK 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 24521357 ↗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 24455821 ↗MalfunctionJan 22, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER'S LOAD WAS FIRED BUT DID NOT TRIGGER THE STAPLES. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146357 ↗MalfunctionDec 26, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE RELOAD GET FIRED BUT STAPLE PINS DOES NOT GET DEPLOYED. MANAGED WITH ANOTHER RELOAD OF TCR75. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23899405 ↗MalfunctionDec 2, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE UNK SURGERY, COULD NOT FIRE FARTHER AFTER FIRED A LITTLE. 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 23694425 ↗MalfunctionDec 2, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BEFORE STAPLING AND AFTER LOADING THE RELOADS TO THE GUN, STAPLERS PINS WERE LOOSE AND IT WAS FALLING OFF. THE PROCEDURE WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692870 ↗MalfunctionSep 15, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES WERE NOT FORMED. ANOTHER RELOAD HAS BEEN SUCCESSFULLY USED AFTERWARDS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052490 ↗MalfunctionSep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ACCORDING TO THE DISTRIBUTOR, THE PRODUCTS PRESENTED PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939636 ↗MalfunctionAug 12, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT STAPLE MISFIRED AND THE DEVICE LOCKED OUT HALF WAY THROUGH. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783511 ↗MalfunctionMay 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THERE WAS BLEEDING. THE SURGEON CERTAINLY KNOWS HOW TO USE THE DEVICE. THE PATIENT BLED 3 DAYS POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018526 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT HAD SIGNIFICANT BLEEDING AFTER USING A TLC75 AND A TX60 STAPLER ON THEM. THE SURGEON CERTAINLY KNOWS HOW TO USE THE DEVICES. BLED 3 DAYS POST OP. PATIENT HAD TO BE BROUGHT BACK TO THE OPERATING ROOM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21725026 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT HAD SIGNIFICANT BLEEDING AFTER USING A TLC75 AND A TX60 STAPLER ON THEM. THE SURGEON CERTAINLY KNOWS HOW TO USE THE DEVICES. BLED 3 DAYS POST OP. PATIENT HAD TO BE BROUGHT BACK TO THE OR.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21722375 ↗MalfunctionMar 4, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD WAS LOADED PROPERLY AND THEN THE SURGEON COULDN¿T FIRE THE STAPLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21516736 ↗MalfunctionMar 4, 2025Failure to Fire; Failure 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 21516290 ↗MalfunctionMar 4, 2025Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STERILITY DEFECT WITH IMPACT ON THE PACKAGES AND DIFFICULT OPENING. +++ INFECTIOUS RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514569 ↗MalfunctionFeb 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN UNKNOWN THE NURSE OPENED THE PACKAGE AND SAW THAT THERE WAS A PIECE OF PLASTIC BROKEN OFF OF THE WINGS OF CARTRIDGE THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21449859 ↗MalfunctionFeb 24, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RESECTION OF BLADDER CANCER 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 21447958 ↗MalfunctionFeb 24, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UROLOGICAL PROCEDURE 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 21447713 ↗MalfunctionFeb 10, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A COLORECTAL PROCEDURES THAT ONE OF THE FIRINGS THE SURGEON SAW THAT THE STAPLES WERE NOT PROPERLY FORMED. DEVICE WAS RELOADED AND THE SURGEON REDID THE STAPLE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343699 ↗MalfunctionJan 13, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 21140155 ↗MalfunctionJan 9, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MATERIAL WAS DEFECTIVE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113521 ↗MalfunctionDec 12, 2024Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A RELOAD PRESENTED DEFECTS AT THE TIME OF THE SHOOTING, THE STAPLES WERE NOT FIRED CORRECTLY, AND IT IS NECESSARY TO OPEN A NEW RELOAD TO CONTINUE THE STAPLING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913650 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.