PROXIMATE TLC75Recalls & reported problems

Summary

The FDA's MAUDE database contains 507 adverse event reports that list this exact device (DI 10705036013211), received between Jul 21, 2015 and Jul 7, 2026 — classified as 14 deaths, 175 injuries, 318 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (150 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 507 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE PATIENT¿S LOBE WAS DESCRIBED AS THICK, PREVENTING THE STAPLER FROM CLOSING INITIALLY. THE SURGEON SUBSEQUENTLY FORCED THE DEVICE TO CLOSE AND HELD COMPRESSION FOR TWO MINUTES. UPON FIRING, A LOUD POP WAS HEARD, AND THE KNIFE DID NOT ADVANCE FURTHER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25738995 ↗
• MalfunctionMay 5, 2026Structural Problem

  IT WAS REPORTED THAT DURING A SMALL-BOWEL RESECTION, WHEN REMOVING THE INSTRUMENT¿S ORANGE PROTECTIVE COVER, THE STAPLES CAME OUT OF THE CARTRIDGE SPONTANEOUSLY. OPENING AN INDIVIDUAL CARTRIDGE PRODUCED THE SAME PROBLEM: THE STAPLES CAME OUT OF IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083370 ↗
• InjuryMay 4, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER-HOURS ACUTE CASE (UROLOGY RE-LOOK PLUS BOWEL RESECTION), THE COLORECTAL COMPONENT WAS PERFORMED BY DR. DURING THE BOWEL RESECTION, A SIGNIFICANT ISSUE OCCURRED INVOLVING THE ETHICON TLC75 DEVICE. THE DEVICE WAS FIRED ONCE WITHOUT INCIDENT AND THE PROCEDURE CONTINUED. THE DEVICE WAS THEN CALLED UPON FOR A SECOND FIRING. THE ASSISTING NURSE (ORTHOPEDIC NURSE, UNFAMILIAR WITH THE DEVICE) HAD NOT, OR DID NOT RECALL TO, UNLOAD, CLEAN, AND RELOAD THE DEVICE. AS A RESULT, THE DEVICE WAS FIRED A SECOND TIME WITH THE FIRST SPENT RELOAD STILL IN PLACE. CONCERNINGLY, THE DEVICE DID NOT LOCK OUT OR OTHERWISE PREVENT FIRING WITH A PREVIOUSLY USED RELOAD. THE KNIFE TRANSECTED THE BOWEL, HOWEVER NO STAPLES WERE DEPLOYED. UPON FIRING, THE SURGEON NOTED AN ABSENCE OF THE NORMAL RESISTANCE HE WOULD EXPECT, BEING VERY FAMILIAR WITH THE DEVICE. THE STANDARD PRESSURE HE APPLIED RESULTED IN THE KNIFE RAPIDLY ADVANCING TO THE END OF THE KNIFE TRACK. ON REFLECTION, THE SURGEON ALSO NOTED THAT THE CLOSING HANDLE PRIOR TO THE SECOND FIRING OPENED WIDER THAN WOULD NORMALLY BE EXPECTED, OPENING TO APPROXIMATELY 90 DEGREES RELATIVE TO THE INSTRUMENT BODY. DR RECTIFIED THE SITUATION B

  Patient problems: Insufficient Information

  MAUDE report 25073267 ↗
• MalfunctionApr 24, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING GASTRECTOMY, THE DEVICE WAS ATTEMPTED TO FIRE, BUT THE DEVICE COULD NOT BE FIRED. 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 24982148 ↗
• MalfunctionApr 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AND UNK PROCEDURE THE STAPLER FIRING, THE BLADE LOCKED EARLY, WHERE IT WAS NOT POSSIBLE TO COMPLETE THE SHOT OR THE FORMATION OF A STAPLE LINE. THE STAPLER WAS REPLACED AND THE SURGERY WAS COMPLETED. IN THE FIRING THERE WERE NO STAPLES THAT CAME LOOSE OR DAMAGE TO THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982107 ↗
• MalfunctionApr 9, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE, WHEN THEY REMOVED THE PRODUCT FROM PACKAGING BOX, IT WAS BROKEN. THE METAL COMPONENT SEPARATED FROM THE PLASTIC COMPONENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831232 ↗
• MalfunctionApr 9, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE, THE OUTER PLASTIC BOX IS DEFECTIVE. THE HANDLE ON THE UPPER PART IS REMOVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831206 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DOCTOR REPORTS DELAYED ACTIVE BLEEDING 48 HOURS AFTER SURGERY AT THE STAPLE LINE. THE ANTICOAGULANT WAS DISCONTINUED IN ORDER TO STABILIZE HIM. STABILIZATION WAS ACHIEVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24792679 ↗
• MalfunctionMar 26, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CAN'T ADVANCE FIRING KNOB. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24703478 ↗
• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING COLON RESECTION PROCEDURE, 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 24665694 ↗
• MalfunctionMar 23, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 24665460 ↗
• MalfunctionMar 16, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE WHICH INSERTS INTO INTRALUMINAL, STAPLER JAMMED/THE BLADE OF STAPLE WOULD NOT RETRACT AND WAS PROTRUDING OUT ON STAPLE AFTER USE AND WAS NOT ABLE TO BE REMOVED FROM THE STAPLER ITSELF SO ANOTHER HAD TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610755 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, A PATIENT CAME BACK WITH POSTOP GI BLEED AFTER USING THE TLC75. CAME BACK 2 TO 3 WEEKS POST OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24475030 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, A PATIENT CAME BACK WITH POSTOP GI BLEED AFTER USING THE TLC75. CAME BACK 2 TO 3 WEEKS POST OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24475024 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLECTOMY WITH COLOSTOMY AND ANASTOMOSIS PROCEDURE. A SMALL ANASTOMOTIC LEAK WITH ASSOCIATED ABSCESS WAS SUBSEQUENTLY IDENTIFIED. THE DEVICE USED DURING THE PROCEDURE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN OR EVALUATION. NO OTHER INFORMATION PROVIDED.

  Patient problems: Abscess; Failure to Anastomose; Post Operative Wound Infection

  MAUDE report 24433279 ↗
• MalfunctionFeb 24, 2026Failure to Form Staple; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE THIN FIRING KNOBS WERE BUMPED FORWARD, THE TECHNICIAN DID NOT RELOAD THE STAPLER; THEREFORE THE FIRST COUPLE OF STAPLES PROXIMAL TO THE STAPLE LINE DID NOT FORM. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24432807 ↗
• MalfunctionFeb 20, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A ILEOSTOMY REVERSAL THE STAPLES AT THE END OF THE STAPLE LINE WERE NOT FULLY CLOSED. THEREFORE, THE TISSUE LAYERS WERE NOT FULLY CLOSED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405414 ↗
• MalfunctionFeb 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSTRUMENT WAS LOCKED DURING FIRING AND SECOND ONE HAD THE SAME PROBLEM. THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401060 ↗
• MalfunctionFeb 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE INSTRUMENT WAS LOCKED DURING FIRING AND SECOND ONE HAD THE SAME PROBLEM. THERE WAS NO DELAY IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401029 ↗
• MalfunctionFeb 18, 2026Failure to Form Staple; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THAT THE STAPLER FAILED. STATED THAT THE STAPLER WAS NOT WORKING. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377614 ↗
• MalfunctionFeb 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 24280764 ↗
• MalfunctionFeb 5, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE FIRST ONE WAS FIRED WITHOUT ANY PROBLEMS. IT COULD NOT BE FIRED WHEN LOADING THE SECOND TCR75. THE CARTRIDGE COLOR WAS BLUE. 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 24270864 ↗
• MalfunctionJan 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING THE COLON RESECTION SURGERY, COULD NOT FIRE. CHANGED ANOTHER RELOAD TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122206 ↗
• MalfunctionJan 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THEY CANNOT LOCKED THE HANDLE AND THE STAPLES WERE MALFORMED. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960878 ↗
• MalfunctionDec 31, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK SURGERY, COULD NOT FIRE FARTHER AFTER FIRED A HALF. 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 23933828 ↗