PROXIMATE TLC55Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10705036013204), received between Jan 2, 2018 and Feb 9, 2026 — classified as 17 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (10 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UPON OPENING THE SECONDARY PACKAGING, THEY DISCOVERED THAT THE PRIMARY PACKAGING HAD ALREADY BEEN OPENED. AS THE PRODUCT IS THEREFORE NO LONGER STERILE AND CONSEQUENTLY UNUSABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296242 ↗
• InjuryNov 10, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GENERAL SURGERY, WHEN THEY FIRED THE STAPLER ON THE ANASTOMOSIS, THE STAPLER GOT STUCK IN THE INTESTINE AND COULD NOT BE OPENED. THEY CUT OUT THE STAPLER OUT OF THE INTESTINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23511212 ↗
• MalfunctionJun 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN WHIPPLE PROCEDURE THE SURGEON WENT TO FIRE THE DEVICE ON THE SMALL BOWEL DURING AN OPEN WHIPPLE PROCEDURE. THE DEVICE CUT AND STAPLED, BUT BOTH ENDS OF THE STAPLE LINE WERE NOT STAPLED PROPERLY SO THE SURGEON SUTURED WITH PDS. NO HARM HAS COME TO THE PATIENT AS THIS WAS OVERSEWN IN THE CASE. REMOVED DEVICE FROM PROCEDURE USING MANUAL OVERRIDE AND REPLACED WITH ANOTHER OF THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306454 ↗
• MalfunctionOct 21, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER DID NOT DEPLOY STAPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495900 ↗
• MalfunctionAug 20, 2024Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THEY TRIED TO TAKE THE PACKAGE OFF, IT HAD RIPPED, AND IT MADE IT BECOME DEEMED UNSTERILE. THEY GOT A NEW DEVICE TO PROCEED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002255 ↗
• MalfunctionDec 8, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN BOWEL SURGERY, WHILE THE SURGEON WAS ATTEMPTING TO PERFORM A SIDE-TO-SIDE ANASTOMOSIS OF THE SMALL INTESTINE, THE SINGLE-USE STAPLER DID NOT FUNCTION APPROPRIATELY. WHEN THE SURGEON OPENED THE STAPLER, THE TWO END WERE NOTED TO BE CROOKED AND NOT COMPLETELY INSERTED TOGETHER (AS PER USUAL). IT WAS TOO LATE TO ABORT THE ANASTOMOSIS, AS THE STAPLER HAD ALREADY FIRED. THE STAPLES APPEARED OKAY. THE SURGEON COMPLETED THE ANASTOMOSIS LINE AND RESECTED THE ANASTOMOSIS. USING A NEW STAPLER, THE SURGEON REDID THE ANASTOMOSIS TO ENSURE INTEGRITY OF THE SUTURE LINE. SURGERY TIME WAS EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291671 ↗
• MalfunctionAug 16, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STERILE PACKAGING COMPROMISED - TOP SHEET NOT SEALED TO PLASTIC BACKING TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557214 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP TO THE BOWEL RESECTION PROCEDURE THE PATIENT HAD TO BE BROUGHT BACK DUE TO BLEEDING NEAR THE STAPLE LINE. ANOTHER ANASTOMOSIS WAS DONE VIA STAPLING. THE PATIENT IS DOING BETTER NOW. DOCTOR STATED THAT HE WAS UNSURE THAT IF IT WAS CAUSED BY THE STAPLE LINE BUT COULD NOT RULE OUT THAT IT DID NOT COME FROM THE STAPLE LINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17249149 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A STAPLE LINE LEAK. STAPLE LINE LEAK. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. PROCEDURE: BLADDER SURGERY.

  Patient problems: Failure to Anastomose

  MAUDE report 16789261 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP TO THE OPEN BOWEL PROCEDURE, THERE WAS INTRA-OP NO BLEEDING. WHILE PATIENT WAS POST-OP BLEEDING WAS FOUND AND RESULTED IN A RE-OP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16664825 ↗
• MalfunctionMar 7, 2023Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event; Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event

  IT HAS BEEN REPORTED THAT THE JAW PART OF THE STAPLER DOES NOT CLOSE EASILY DURING THE APPLICATION AND THAT AFTER EACH FIRING, THERE IS BLEEDING IN THE TISSUE AND OPENINGS IN A CERTAIN LINE OF THE TISSUE. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE: UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494680 ↗
• InjuryMar 7, 2023Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, DEVICE MISFIRED, LED TO LEAK. USING ANOTHER STAPLER TO COMPLETE THE SURGERY. EXTENDED STAY SINCE THE PATIENT LEAKED POST-OP. INCREASED STAY AT ICU IN HOSPITAL.

  Patient problems: Failure to Anastomose

  MAUDE report 16494515 ↗
• InjuryMar 6, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAPLER MISFIRED TWICE IN THE SAME SURGERY. PROCEDURE: HEMICOLECTOMY.

  Patient problems: Failure to Anastomose

  MAUDE report 16485335 ↗
• MalfunctionJun 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE RECEIVED HAS BEEN CLASSIFIED AS AN UNRECONCILED BLIND UNIT. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735235 ↗
• MalfunctionApr 15, 2022Failure to Fire; Failure to Fire

  USER FACILITY MW (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117462 ↗
• MalfunctionFeb 25, 2022Failure to Fire; Mechanical Jam; Failure to Fire; Mechanical Jam

  IT WAS REPORTED THAT DURING THE UNKNOWN PROCEDURE, WHILE THE SURGERY RESIDENT WAS FIRING STAPLER, THE BLADE GOT STUCK. HE WAS ABLE TO SEPARATE STAPLER PIECES TO REMOVE FROM BOWEL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598782 ↗
• MalfunctionDec 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A GASTRECTOMY, THE APPLIER GOT STRUCK DURING FIRST FIRING AND THE STAPLES IN THE RELOADS POPPED OFF WHILE REMOVING THE RETAINING CAP. THE SURGERY WAS DELAYED BY 20-MINUTES. NEW APPLIER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13052501 ↗
• MalfunctionDec 1, 2021Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A COLON RESECTION THE TLC55 WITH BLUE RELOAD DID NOT SEAL THE COLON, AND FOLLOWING THE FIRING OF THE STAPLER, STOOL LEAKED OUT AT THE START OF THE STAPLE LINE. HE ENSURED THAT TISSUE WAS NOT CROTCHED IN THE JAWS BEFORE FIRING. HE ALSO OBSERVED BLEEDING MORE AFTER THE FIRINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908473 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN A LEFT COLECTOMY ON APRIL SIXTH, CASE PROCEEDED UNEVENTFULLY. NO CHALLENGES INTRAOPERATIVELY. POSTOPERATIVELY, THE PATIENT DEVELOPED BLOODY BOWEL, SIGNIFICANT HEMATOCRIT DROP, INTRA-ABDOMINAL AND INTRALUMINAL BLEEDING. THE PATIENT WAS READMITTED FOR OBSERVATION. NO OTHER INTERVENTION, NO TRANSFUSION AND THE PATIENT IS HOME NOW. THE TLC55 WAS USED TO TRANSECT THE BOWEL AND COMPLETE THE ANASTOMOSIS. TX60B WAS ALSO USED TO CLOSE THE COLOSTOMY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11913230 ↗
• MalfunctionJan 19, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE THE STAPLER WAS USED A COUPLE OF TIMES SUCCESSFULLY AND THE LAST LOAD THEY TRIED TO FIRE DID NOT EXPEL ANY STAPLES. BUT THE DOCTOR SAID THAT IT DID CUT. THERE WERE NO POOR OUTCOMES DUE TO THIS. THE SURGEON WAS ABLE TO FINISH THE SURGERY. SALES REP WAS NOT IN THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194452 ↗
• MalfunctionDec 8, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, "GAP IN STAPLE LINE WHEN FIRING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971412 ↗
• MalfunctionOct 14, 2020Failure to Cut; Failure to Fire; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT THE STAPLER DIDN'T STAPLE AND THE KNIFE TARED THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10678790 ↗
• MalfunctionFeb 5, 2020Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE MALFORMED STAPLES AT THE PROXIMAL END OF THE STAPLE LINE. TWO BLUE RELOADS WERE USED AND THE SAME ISSUE OCCURRED. A SECOND LIKE STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674246 ↗
• MalfunctionJan 31, 2020Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN UNPACKING THE STAPLER, IT LOOKED LIKE IT WAS ALREADY FIRED. THE STAPLERS WERE NOT ATTACHED TO THE RELOAD AND WAS LAYING LOOSE IN THE PACKAGING. THE SURGERY WAS DELAYED BY 5-MINUTES. REPLACED WITH SAME LIKE DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9653183 ↗
• InjuryDec 2, 2019Failure to Form Staple

  IT WAS REPORTED BY THE SALES REP THAT DURING A BOWEL RESECTION, THREE STAPLERS, ONE TLC75 AND TWO TLC55 STAPLERS, PRODUCED MALFORMED STAPLES AND HAD EXCESSIVE BLEEDING ON THE STAPLE LINES. ALL 3 STAPLERS ALLEGEDLY ONLY FIRED 1/3 OF THE WAY AND JAMMED, NOT ALLOWING THE SURGEON TO CONTINUE THE COMPLETE FIRE. SURGEON CLAIMS THE TISSUE WAS NOT TOO THICK OR TOO MUCH TISSUE ALONG THE STAPLE LINE. THE PROCEDURE WAS DELAYED BY AN UNKNOWN AMOUNT OF TIME. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. UNKNOWN HOW BLEEDING WAS CONTROLLED. ACCORDING TO THE SURGEON, HOSPITAL STAY WAS EXTENDED. TO WHAT EXTENT, I DON¿T KNOW. PATIENT WAS LATER DISCHARGED. PATIENT IS OK.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9396840 ↗