Proximate TCR10Recalls & reported problems
Ethicon Endo-Surgery, LLC · Proximate Linear Cutter Reloads (Standard)-100mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Proximate TCR10 linear cutter reload is a disposable stapling cartridge used to join tissue inside the body during surgery. Reports mostly describe the reload failing to fire or staples not forming properly, along with cracked or already-broken cartridges and one package arriving with loose staples; a few mention bleeding and tissue not joining. There are 43 reports, 6 injuries and no deaths. 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
- 43
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705036003045), received between Jan 26, 2018 and Apr 3, 2026 — classified as 6 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (12 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 Fire12
- Failure to Form Staple11
- Adverse Event Without Identified Device or Use Problem6
- Material Integrity Problem4
- Break3
- Insufficient Device Problem Information3
- Manufacturing, Packaging or Shipping Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient14
- Failure to Anastomose4
- Hemorrhage/Blood Loss/Bleeding2
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, IN PRE-OP, NURSE FOUND CRACK ON TCR10. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781517 ↗MalfunctionApr 2, 2026Failure to Form Staple
IT WAS REPORTED THAT USING TCR10 RELOAD FOR A DIAG LAP+ SEGMENTS RESECTION + ANASTOMOSIS OF JEJUNUM. THE TCR10 GOT STUCK WHILE FIRING & STAPLES WERE NOT FORMED PROPERLY. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769439 ↗MalfunctionMar 30, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, TCR10 ALREADY BROKEN. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729568 ↗MalfunctionMar 13, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TCR10 IS ALREADY BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592925 ↗MalfunctionDec 18, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER RELOAD CAME OUT OF THE PACKAGE WITH LOOSE STAPLES AS IF IT HAD ALREADY BEEN USED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838165 ↗MalfunctionAug 11, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED. THE DEVICE WAS ROUTINELY USED IN THIS FACILITY. THERE WAS NO EFFECT ON THE PATIENT. 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 22771355 ↗MalfunctionJun 19, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT ABLE TO FIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293227 ↗MalfunctionFeb 3, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A GASTRECTOMY THE RELOAD DID NOT FIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21292415 ↗MalfunctionOct 22, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE END OF THE RELOAD SNAPPED WHEN IT WAS BEEN INSERTED IN TO THE LINEAR CUTTER. A SMALL PIECE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20506590 ↗MalfunctionAug 22, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT STAPLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039480 ↗MalfunctionJun 10, 2024Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE STAPLER DID NOT FORM PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19504068 ↗InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST OP TO A COLECTOMY, THE TCR10 HAVE BEEN USED IN PATIENT BEFORE 1 MONTH. DR HAS REPORTED STAPLE LINE OPENED UP AFTER 1 MONTH.
Patient problems: Failure to Anastomose
MAUDE report 17833522 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR USED TCR10 TO ANASTOMOSIS COLON AFTER PASS 5 DAYS, PATIENT NEED TO REDO SURGERY BECAUSE DOCTOR FOUND STAPLER LINE LEAKAGE.
Patient problems: Failure to Anastomose
MAUDE report 17365153 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DOCTOR USED TCR10 TO ANASTOMOSIS COLON AFTER PASS 5 DAYS, PATIENT NEED TO REDO SURGERY BECAUSE DOCTOR FOUND STAPLER LINE LEAKAGE.
Patient problems: Failure to Anastomose
MAUDE report 17365147 ↗MalfunctionJul 5, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A ILEOSTOMY CLOSURE AND AFTER USING A LINEAR STAPLER, THE SURGEON REALIZED THAT ON ONE SIDE OF THE APPLICATION, THERE WAS NO STAPLE LINE. SO 2 LINES ON ONE SIDE OF THE CUTTING LINE, AND 0 LINE ON THE OTHER SIDE. THE SURGEON HAD TO DO EVERYTHING AGAIN MANUALLY. THERE WAS A SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17259233 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE THE STAPLERS LED TO BLEEDING AFTER FIRING. THERE WAS INTERNAL BLEEDING IN THE GASTRECTOMY CASE AFTER THE DEVICE WAS STAPLED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17117897 ↗InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE THE STAPLERS LED TO BLEEDING AFTER FIRING. THERE WAS INTERNAL BLEEDING IN THE GASTRECTOMY CASE AFTER THE DEVICE WAS STAPLED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17117851 ↗MalfunctionApr 14, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, WHEN FIRED, KNIFE MOVED TILL IN THE MIDDLE. IT WAS SAFELY RETRIEVED AND NEW RELOAD WAS USED TO FINISH. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742974 ↗MalfunctionFeb 27, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS BROKEN WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16447180 ↗MalfunctionNov 11, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CUTTER WAS BROKEN BEFORE USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15779545 ↗MalfunctionNov 11, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CUTTER WAS BROKEN BEFORE USE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15779522 ↗MalfunctionAug 25, 2022Failure to Fire; Failure to Fire
IT WAS REPORTED THAT THE SURGEON USED THE TCR10 RELOAD FOR A SUB TOTAL GASTRECTOMY PROCEDURE. SURGEON TRIED TO FIRE THE SECOND RELOAD FOR THE RESECTION. THE GUN GOT STRUCK MID-WAY. TWO RELOADS DIDN'T COMPLETE THE FIRING AND HAD TO USE A THIRD ONE. SURGERY WAS DELAYED BY 15-MINUTES. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15294647 ↗MalfunctionAug 3, 2022Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING INTRAOPERATIVE GASTRECTOMY PROCEDURE, SURGEON DETECTED THAT THE RELOAD WAS NOT TRIGGERING ALL STAPLES. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15157674 ↗MalfunctionJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE DEVICE RECEIVED HAS BEEN CLASSIFIED AS AN UNRECONCILED BLIND UNIT. NO FURTHER INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14914180 ↗MalfunctionDec 14, 2021Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE OPEN HEPATECTOMY SURGERY, AFTER INSTALLED RELOAD CLOSED THE JAW, BUT COULD NOT OPEN THE JAW ANYMORE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13002099 ↗
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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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