PROXIMATE TRT10Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705036003236), received between Aug 22, 2018 and Apr 10, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, PROXIMATE RELOAD COULDN'T FIRE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840865 ↗
• MalfunctionFeb 27, 2026Structural Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE LEG STAPLE COME OUT BEFORE FIRING. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472530 ↗
• MalfunctionFeb 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TLC RELOAD COULDN'T FIRE. NO PATIENT CONSEQUENCES WERE REPORTED. NO INCIDENCE OF INFECTION OR INFLAMMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280695 ↗
• MalfunctionMay 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE WHERE A STAPLER AND A GREEN LOAD WAS USED, AT THE END OF THE SURGERY THEY REALIZED THAT ONE OF THE LOADS DID NOT STAPLE CORRECTLY, PRESENTING OPENING IN THE STAPLE ZONE IN THE MIDDLE OF THE DUODENUM. THE DOCTOR REPORTED THAT HE MADE USE OF THE CORRECT TECHNIQUE OF PREPARATION OF THE TISSUE, AND COMPRESSION OF THE TISSUE TO PERFORM THE STAPLING. HOWEVER, WHEN MAKING A FINAL REVIEW FOR PATIENT CLOSURE, HE NOTICED THIS OPENING IN THE MEDIAL PART OF THE DUODENUM. FINALLY, MANUAL SUTURE WAS PERFORMED TO CLOSE THIS OPENING AND REINFORCEMENT SUTURE IN THE OTHER AREAS OF CLAMP, FINISHING THE SURGERY SUCCESSFULLY, DOCTOR REPORTED THAT PATIENT IS WELL. THERE WERE NO PATIENT CONSEQUENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046365 ↗
• MalfunctionMay 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE WHERE A STAPLER AND A GREEN LOAD WAS USED, AT THE END OF THE SURGERY THEY REALIZED THAT ONE OF THE LOADS DID NOT STAPLE CORRECTLY, PRESENTING OPENING IN THE STAPLE ZONE IN THE MIDDLE OF THE DUODENUM. THE DOCTOR REPORTED THAT HE MADE USE OF THE CORRECT TECHNIQUE OF PREPARATION OF THE TISSUE, AND COMPRESSION OF THE TISSUE TO PERFORM THE STAPLING. HOWEVER, WHEN MAKING A FINAL REVIEW FOR PATIENT CLOSURE, HE NOTICED THIS OPENING IN THE MEDIAL PART OF THE DUODENUM. FINALLY, MANUAL SUTURE WAS PERFORMED TO CLOSE THIS OPENING AND REINFORCEMENT SUTURE IN THE OTHER AREAS OF CLAMP, FINISHING THE SURGERY SUCCESSFULLY, DOCTOR REPORTED THAT PATIENT IS WELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046362 ↗
• MalfunctionJan 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT LOOSE ANY STAPLES DURING USE. 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 21054803 ↗
• MalfunctionMay 9, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PINS OF THE TRT WAS ALREADY FALLING OUT FROM THE RELOADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280709 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLECTOMY THE TRT10 STAPLER LINE LEAKED.

  Patient problems: Failure to Anastomose

  MAUDE report 17833702 ↗
• MalfunctionSep 20, 2023Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A GASTRECTOMY THE TRT10 WAS LOADED IN 100MM PROXIMATE LINEAR CUTTER AFTER FIRING 1 TCR10. STAPLER PINS WERE COMPLETELY OUT, STAPLER LINE WAS RUPTURED AND THERE WAS A LEAK. THE SURGERY WAS PROLONGED 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781625 ↗
• MalfunctionJun 15, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AFTER THE DEVICE WAS FIRED, STAPLE LEG DIDN'T MAKE A FULL B SHAPE. RETRIEVED RELOAD AND AS MUCH AS STAPLES AS POSSIBLE, HAND SUTURED CUT SITE AND FINISHED SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139712 ↗
• MalfunctionJan 31, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN FIRED THE DISTAL PORTION OF THE STAPLE DIDN¿T MAKE B SHAPE COMPLETELY. A NEW RELOAD WAS USED TO FINISH THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270841 ↗
• MalfunctionJul 29, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN RELOAD WAS OPEN, BOTTOM SIDE SURFACE (OPPOSITE FROM STAPLE LINE) WAS UNEVEN. UNABLE TO USE IT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129022 ↗
• MalfunctionNov 22, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE TRT10 STAPLER IS NOT FORMED AND INITIATED. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851542 ↗
• MalfunctionAug 22, 2018Positioning Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON TRIED TO FIRE THE DEVICE, THE KNIFE DID NOT GO FORWARD. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804315 ↗