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PROXIMATE TRT75Recalls & reported problems

Ethicon Endo-Surgery, LLC · PROXIMATE LINEAR CUTTER RELOAD (Thick) · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036013334), received between Jan 8, 2021 and Feb 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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.

Most reported problems

Device problems

  • Failure to Fire3
  • Failure to Cut1
  • Failure to Form Staple1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 1, 2023Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PINS WERE NOT FOUND IN THE STAPLER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16276930 ↗
  • MalfunctionAug 1, 2022Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT THE TRT75 MISFIRED (DIDN¿T FIRE FULLY). HCP HAS USED ANOTHER CARTRIDGE TO COMPLETE THE SURGERY. THE SURGERY WAS DELAYED BY 20-MINUTES AND SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. PROCEDURE: UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15138961 ↗
  • MalfunctionSep 3, 2021Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE "RELOAD PINS WERE NOT DEPLOYED." IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12421771 ↗
  • MalfunctionJan 8, 2021Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

    IT WAS REPORTED THAT DURING A HEMICOLECTOMY, "LINEAR RELOAD THAT IS PASSED TO BE USED IN INTESTINAL RESECTION PLUS ANASTOMOSIS OF THE DRA IS ASSEMBLED ON THE TLC 75 STAPLER AND WHEN IT IS FIRED, THE STAPLER STICKS AND WHEN TRYING TO UNLOCK BECAUSE IT WAS HOLDING THE TISSUE, THE REFILL SHOOT. IT DOES NOT HARM THE PATIENT." THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11139090 ↗

Other STAPLE, IMPLANTABLE devices

All STAPLE, IMPLANTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.