PROXIMATE TCT75Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705036013150), received between Aug 13, 2018 and May 1, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCTECTOMY SURGERY, WHEN FIRING, THE STAPLES COULDN'T BE DEPLOYED. CHANGED ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941581 ↗
• MalfunctionMar 25, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN ABDOMEN COLON PROCEDURE THE STAPLER WOULD NOT OPEN NO MORE AFTER THE 3TH RELOAD. A NEW STAPLER WAS OPEN AND USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686763 ↗
• MalfunctionFeb 21, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A BOWEL ANASTOMOSIS THE DEVICE, WHEN RELOADED WAS NOT FIRING CORRECTLY. ATTEMPTED TO FIRE A TCT75 WITH A BLUE RELOAD THAT DIDN¿T WORK. ONE WHOLE ROW OF STAPLES DID NOT GO THROUGH, SO THEY HAD STAPLES EVERYWHERE . STAPLER WAS NOT CUTTING PROPERLY AND ONLY WENT HALF WAY. THE SURGERY WAS DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL BOWEL HAD TO BE TAKEN TO PROPERLY COMPLETE PROCEDURE DUE TO ISSUES WITH FIRING AND STAPLE LINE,

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 18747642 ↗
• MalfunctionApr 10, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE GASTRIC SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709282 ↗
• MalfunctionDec 28, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN UNKNOWN SURGERY, THE PACKAGE SEAL WAS OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060855 ↗
• MalfunctionDec 21, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023108 ↗
• MalfunctionMar 4, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667396 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGERY THE DOCTOR PERFORMED ON JULY 17TH USING THE TCT75 TO STAPLE THE STOMACH OF A GUNSHOT WOUND VICTIM HAD TO BE BROUGHT BACK TO SURGERY DUE TO A STAPLE LINE LEAK ON THE STOMACH.

  Patient problems: Failure to Anastomose

  MAUDE report 12373982 ↗
• MalfunctionJul 12, 2021Failure to Form Staple; Failure to Cut; Failure to Fire; Failure to Form Staple; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE FOR RESTORATION OF CONTINUITY ON ILEOSTOMY FIRST USE OF DEVICE THEN RELOAD: THE STAPLER GOT JAMMED. USE OF SECOND DEVICE FROM THE SAME LOT: FIRST USE BLOCKAGE. CONTINUE THE PROCEDURE WITH BLUE STAPLER. FIRST OPERATION OK THEN PLACEMENT OF A GREEN REFILL ON THIS DEVICE: STAPLING PART OF THE COLIC. AT THE REMOVAL: STAPLES PARTIALLY TORE THE ANASTOMOSIS WHICH HAD TO BE REINFORCED WITH MANUAL STITCHES VIA SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149950 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EIGHT DAYS POST OP TO A SIGMOID COLECTOMY THE PATIENT PRESENTED NOT FEELING WELL. EXPLORATORY SURGERY REVEALED THE STAPLE LINE HAD FAILED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING FINE.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 10683685 ↗
• MalfunctionJun 22, 2020Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS AN INCOMPLETE CLOSURE AND PREMATURE CUT AT STAPLE LINE. IT ALLOWED BOWEL CONTENTS TO SPILL INCREASING THE RISK OF CONTAMINATION. IT WAS UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10178882 ↗
• MalfunctionJun 10, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE CLOSURE WAS INCOMPLETE. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137845 ↗
• MalfunctionMay 11, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THERE WAS A PRODUCTION MALFUNCTION. THE STAPLER MISFIRED AND STAPLES EJECTED BUT DID NOT ENGAGE TISSUE PROPERLY. AN ADDITIONAL FIVE CENTIMETRES OF TISSUE HAD TO BE REMOVED. NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043450 ↗
• MalfunctionApr 23, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RIGHT OPEN COLECTOMY ON THE THIRD FIRING THE STAPLES FORMED UNTIL THE LAST INCH THEN THE KNIFE BLADE LOCKED. THEY HAD TO OPEN AND REMOVE FROM TISSUE. THE SURGEON STATED HE MAY NOT HAVE CLOSED THE DEVICE ENTIRELY. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990682 ↗
• MalfunctionSep 25, 2019Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THERE WAS SOMETHING WRONG WITH THE STAPLES, MISSHAPEN. THIS CAUSED ISSUES WITH THE TISSUE BEING RESECTED. SURGEON CHOSE TO USE ANOTHER PRODUCT TO COMPLETE SURGERY. THERE WAS NOT A PATIENT INJURY. THE UNDERSTANDING WAS THAT THE STAPLER MISFIRED AND THAT THE STAPLES WERE MALFORMED, BUT THERE WAS NOT AN INJURY. SOME OF THE STAPLES THAT COME OUT OF THE DEVICE WERE SAVED AND THEY ARE WITH THE STAPLER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120277 ↗
• MalfunctionSep 6, 2019Failure to Form Staple; Failure to Fire

  PARTIAL FIRE & MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE REDUCTION OF STOMA SURGERY, COULD NOT FIRE FARTHER AFTER FIRED 1/2 WITH TCT75 FOR SIDE-TO-SIDE ANASTOMOSIS. AFTER OPENING THE JAWS, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE AND ALSO FOUND THERE WAS A STAPLE IN THE GROOVE OF THE ANVIL. THEN CLEANED THE JAW AND REPLACED A NEW RELOAD TCR75, BUT THE EVENT HAPPENED AGAIN. SUTURE WAS USED 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 8969036 ↗
• MalfunctionMar 15, 2019Misfire

  IT WAS REPORTED THAT WE HAVE HAD AN INCIDENT WITH THE PRODUCT. WE HAVE HAD 2 INSTANCES WHERE THE CARTRIDGE HAS MISFIRED. WE HAVE ISOLATED THE REMAINING STOCK FROM THIS BATCH, WE ONLY HAVE 1 ITEM FROM THE SAME BATCH. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PROCEDURE WAS A LAPAROTOMY FOR A BOWEL OBSTRUCTION, WE USED THE TCT TO PERFORM AN ILEOCOLIC BYPASS. WHEN THE FIRST STAPLE FAILED WE PUT A 2ND CARTRIDGE IN THE ORIGINAL GUN. THIS ALSO MISFIRED. THERE WAS ENOUGH STAPLES BETWEEN THE TWO TO RESECT THE BOWEL. THE SAME GUN MISFIRED TWICE. ON THE FIRST FIRING AND THEN WITH THE SUBSEQUENT FIRING WITH A FRESH TRT75. WHEN THE TCT WAS FIRED INSTEAD OF FIRING ALL OF THE STAPLES ACROSS THE BOWEL ONLY THE MIDDLE SECTION DEPLOYED INTO BOWEL. THE STAPLES AT BOTH ENDS OF THE CARTRIDGE REMAINED. (AS CAN BE SEEN ON ORIGINAL PHOTO). THE ONES ON THE BOWEL WERE FORMED PROPERLY AND THE STAPLE LINE COMPLETE AND CUT PROPERLY BUT ONLY BECAUSE THE BOWEL WAS NARROW. HAD THE BOWEL BEEN WIDER EACH EDGE WOULD HAVE HAD NO STAPLES IN AS THESE WERE LEFT BEHIND IN CARTRIDGE. THE SURGEON USED A REPLACEMENT CARTRIDGE AND EXACTLY THE SAME THING HAPPENED. THERE WERE NO PATIENT CONSEQUENCES OR CHANGE IN CARE. THE A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424473 ↗
• MalfunctionSep 14, 2018Misfire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON USING THE TLC LINEAR ON THE STOMACH WHEN IT MISFIRED, IT DID NOT FIRE SOME STAPLES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877882 ↗
• MalfunctionAug 13, 2018Failure to Form Staple

  IT WAS REPORTED BY THAT DURING A LOBECTOMY, THE STAPLES DID NOT FORM PROPERLY, THEY WERE STICKING STRAIGHT UP. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776969 ↗
• MalfunctionAug 13, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOBECTOMY, THAT THE STAPLES DID NOT FORM PROPERLY, THEY WERE STICKING STRAIGHT UP. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776932 ↗