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PROXIMATE TRD75Recalls & reported problems

Ethicon Endo-Surgery, LLC · Proximate Linear Cutter Reloads (Gold). · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036003229), received between Jul 30, 2020 and Dec 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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

  • Material Integrity Problem2
  • Difficult to Insert1
  • Failure to Fire1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 20, 2021Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A PART OF THE CARTRIDGE WAS DEFORMED SO THAT IT COULD NOT BE LOADED INTO THE JAW. 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 13042759 ↗
  • MalfunctionSep 24, 2021Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING A PROCEDURE FOR THE TRANSVERSE COLON CANCER, THE PROXIMAL END OF THE CARTRIDGE WAS BROKEN OFF AND THE DEVICE COULD NOT BE FIRED AT THE FIRING OF FEEA. ANOTHER CARTRIDGE 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 12525209 ↗
  • MalfunctionJul 30, 2020Failure to Fire; Failure to Fire

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED RADICAL GASTRECTOMY SURGERY, THE DEVICE WOULD NOT FIRE. CHANGED TO ANOTHER RELOAD TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10346944 ↗

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.