PROXIMATE TLC10Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10705036003120), received between Jun 7, 2018 and Sep 21, 2026 — classified as 1 death, 19 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (34 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

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840738 ↗
• MalfunctionSep 8, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668577 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, A PIN FELL OUT FROM THE DEVICE AND DEVICE WAS UNABLE TO BE USED AFTERWARDS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176112 ↗
• InjuryApr 13, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN ANTERIOR RESECTION OF RECTO SIGMOID COLON, CREATION OF END COLOSTOMY, RECTUS SHEATH CATHETER INSERTION X2. LINEAR STAPLER MISFIRED WHILE STAPLING ACROSS LARGE BOWEL. STAPLES FIRED, BUT DID NOT CURL. UPON REALIZING, SURGEON ASKED FOR A RELOAD. STAPLER MISFIRED A SECOND TIME. AGAIN, STAPLER FIRED, BUT THE STAPLES DID NOT CURL. ADDITIONAL TIME UNDER ANESTHESIA AND PROLONGED CARE.

  Patient problems: Insufficient Information

  MAUDE report 24865138 ↗
• MalfunctionApr 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A JOINT COLORECTAL/RENAL CASE - LAPAROTOMY. THE FIRST TCL FIRED NORMALLY FOR THE FIRST TWO TIMES BUT THIRD TIME HAD ISSUES WHEN THE WHITE CASING FELL OFF FROM THE ANVIL HALF. THEY OPENED A SECOND TCL AND FOUND THE ANVIL HALF CASING WAS A BIT LOOSE BUT STILL PROCEEDED WITH FIRING. REPORTED NO PATIENT HARM FROM THE FIRING. THE METAL PIN ON THE FIRST TCL WAS MISSING. IT WAS FOUND ON THE FLOOR EVENTUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808832 ↗
• MalfunctionDec 9, 2025Failure to Form Staple

  AFTER USING PROXIMATE TLC10 STAPLER 100MM LINEAR CUTTER, NOTICED 1/3 OF THE STAPLES HAD NOT ENGAGED ON ONE OF THE STAPLE LOADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756548 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAP PARTIAL COLECTOMY WITH REMOVAL OF TERMINAL ILEUM, A TLC10 STAPLER WITH A TCR10 RELOAD WAS IN USE AND IT WAS NOTICED THAT THE DISTAL 1/3 OF THE STAPLES HAD NOT ENGAGED. STAPLE LINE WAS OVER SEWN TO COMPLETE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695145 ↗
• MalfunctionAug 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED PROXIMAL GASTRECTOMY, THE STAPLES AT THE ROOT DID NOT APPLY THE ENTIRE LAYER, SO THE MUSCLE LAYER AND SEROUS MEMBRANE WERE FALLEN OFF. THE DOCTOR HIMSELF FIRED THE DEVICE, BEING CAREFUL NOT TO TAKE IN TOO MUCH OF THE BASE, HE SAID. NO PHOTOS OR VIDEOS WERE AVAILABLE. THE DEVICE WAS USED ON THE GASTRIC BODY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902510 ↗
• MalfunctionAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SEMI-OPEN ROBOT-LAPAROSCOPIC DISTAL GASTRECTOMY (RDG), THE MUSCLE LAYER AT THE ROOT PART HAS FALLEN OFF. THE SALES REP WAS PRESENT TO CHECK THAT THE TISSUE HAD NOT BEEN EXCESSIVELY INCORPORATED, BUT IT IS THOUGHT THAT IT WAS WITHIN THE RANGE OF PROPER USE. ADDITIONAL SUTURE WAS PERFORMED 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 22748838 ↗
• MalfunctionJun 24, 2025Failure to Fire; Material Integrity Problem; Failure to Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY, RIGHT HEMICOLECTOMY, PARTIAL LIVER RESECTION AND POSSIBLE STOMA THAT ON THE FORTH FIRING AFTER PASSING THE DEVICE TO THE SURGEON, THE SURGEON OPEN AND CLOSED THE DEVICE A FEW TIMES BEFORE ATTEMPTING TO FIRE WHERE THE DEVICE LOCKED OUT. ANOTHER WAS USED TO CONTINUE WITH THE PROCEDURE. AFTER INSPECTION OF THE DEVICE IT WAS SEEN THAT A PIECE OF THE RELOAD SNAPPED OFF IN THE BACK OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318574 ↗
• MalfunctionJun 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE GOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306977 ↗
• MalfunctionJun 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLECTOMY THE TLC100 WAS GIVEN TO US FROM STAFF IN OR7. REPORTED AS FAULTY. SUBSEQUENTLY TOLD THAT IT WAS OPENED FOR FIRST FIRING AND FAILED TO FIRE; LOCKOUT THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210811 ↗
• MalfunctionMay 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE TWO ORANGE FIELDS FROM THE RELOAD AND SOME IN THE STAPLER COULD NOT BE FIRED, A NEW DEVICE WAS OPENED. NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985460 ↗
• MalfunctionMar 20, 2025Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  PER USER FACILITY MEDWATCH FORM, MW#: (B)(4), DURING RIGHT COLECTOMY PROCEDURE; WHEN THE SURGEON ATTEMPTED TO STAPLE THE BOWEL, THE STAPLER MALFUNCTIONED AND SNAGGED. NO HARM TO PATIENT. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652249 ↗
• MalfunctionMar 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE THERE WAS A BROKEN HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596971 ↗
• MalfunctionMar 5, 2025

  WHEN THE SURGEON ATTEMPTED TO STAPLE THE BOWEL, THE STAPLER MALFUNCTIONED AND SNAGGED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525108 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FIRING NOT POSSIBLE DUE TO TRIGGER MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404995 ↗
• MalfunctionFeb 18, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING COLECTOMY PROCEDURE; THEY HAD A TLC10 STAPLER DISENGAGE INCORRECTLY. GOT ANOTHER STAPLER TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403155 ↗
• MalfunctionFeb 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT, DURING A PANCREATICODUODENECTOMY, THE STAPLES WERE NOT DEPLOYED ON THE INNER LINE OF THE TWO LINES WHEN THE DOCTOR CHECKED THE RESECTION PART AFTER FIRING. THE DOCTOR DID NOT FEEL ANY DIFFERENCE FROM THE USUAL WHEN FIRING. THE DOCTOR WAS EXPERIENCED WITH THIS DEVICE. ADDITIONAL SUTURE WAS PERFORMED 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 21343493 ↗
• MalfunctionSep 9, 2024Failure to Fire; Firing Problem; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A RIGHT HEMI COLECTOMY, OPEN CASE, THE SURGEON FIRED THE DEVICE THE FIRST TIME WHICH WORKED FINE. THE DEVICE WAS RELOADED AS NORMAL AND WHEN THEY STARTED THE FIRING SEQUENCE IT WOULD ONLY FIRE ¼ OF THE WAY UP. THE STAPLES DEPLOYED AND THE KNIFE CUT BUT THE SEQUENCE WOULDN¿T COMPLETE SO THEY HAD TO RETURN USING THE FIRING KNOB TO THE STARTING POINT. THE SURGEON COMMENTED IT FELT STIFF. OPENED A NEW DEVICE WHICH WORKED FINE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176415 ↗
• MalfunctionJul 16, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHILE FIRING THE RELOAD WAS MISFIRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750486 ↗
• MalfunctionJun 11, 2024Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE IN THE MIDDLE OF THE CARTRIDGE FELL OUT AND COULD NOT BE SUTURED. THE STAPLE WAS UNFORMED. 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 19510090 ↗
• MalfunctionApr 3, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE FAILED TO DEPLOY AFTER PLACEMENT OF A RELOAD DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032959 ↗
• MalfunctionFeb 26, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, SURGEON USED TLC10 FOR THE COLO RESECTION HE FIRED THE STAPLE AFTER 15 SECOND, IT STUCK IN THE MIDDLE AND CANNOT PUSH COMPLETE. HE TRIED TO COMPLETE THE FIRE BUT IT FAILED. AT THE END, HE HAS TO FORCE TO OPEN AND THE STAPLE STILL INTACT IN THE TLC10. HE OPENED ANOTHER TLC10 AND COMPLETED THE CASE. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785145 ↗
• MalfunctionFeb 23, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE FEELS STIFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771717 ↗