PROXIMATE TX60BRecalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 10705036003342), received between Dec 15, 2017 and Sep 30, 2026 — classified as 3 deaths, 43 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (66 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 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946430 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  It was reported that during an unknown surgery, the TX60B stapler did not form the staples correctly. Was there any harm to the reported patient or user? No. Was there a significant delay? Yes. How long was it delayed (minutes)? 30-50 minutes, they had to do the anastomosis manually, as the staples were not formed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772686 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ILEOCECECTOMY PROCEDURE, THE SURGEON CLOSED THE COMMON ENTEROTOMY USING A TX STAPLER. ON POSTOPERATIVE DAY 1, THE PATIENT DEVELOPED A LEAK AND WAS TAKEN BACK TO SURGERY. UPON RE-EXPLORATION, IT WAS OBSERVED THAT THE STAPLED SITE APPEARED COMPLETELY OPEN, MEASURING APPROXIMATELY 3¿4 CM IN LENGTH. THE SURGEON SUSPECTED A POTENTIAL FAILURE OF THE TX STAPLER; HOWEVER, NO ISSUES WERE NOTED WITH THE DEVICE DURING THE INITIAL PROCEDURE.

  Patient problems: Failure to Anastomose

  MAUDE report 25331327 ↗
• MalfunctionMay 25, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLERS DID NOT DEPLOY STAPLES WHEN FIRED. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270385 ↗
• MalfunctionMay 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A COLECTOMY, THE STAPLER FIRED ON COLON TISSUE AS USUAL, BUT NO STAPLES DEPLOYED FROM STAPLER. NO STAPLES COULD BE VISUALIZED IN STAPLER. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073134 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT OPEN SIGMOID COLECTOMY ON MARCH 20TH. PATIENT WAS TAKEN BACK INTO SURGERY ON MARCH 27TH. AFTER REOPENING PATIENT, THE SURGEON SAID THAT THE STAPLE LINE WAS GAPING OPEN.

  Patient problems: Failure to Anastomose

  MAUDE report 24840957 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SURGEON CLOSED THE STAPLER ON NORMAL THICKNESS SMALL INTESTINE AND FIRED IT. THE STAPLER APPEARED TO FIRE FINE. UPON REMOVAL, THE SURGEON NOTED THAT THE DISTAL END OF THE STAPLE LINE HAD COMPLETELY UNFORMED STAPLES, BUT THE PROXIMAL SIDE WAS CORRECTLY FORMED. THE SURGEON WAS ABLE TO EXTRACT SEVERAL STAPLES THAT HAD NOT FORMED. THE SURGEON STATE THAT THE TISSUE WAS NOT ABNORMALLY THICK, AND THE STAPLER APPEARED TO FIRE NORMALLY, AND THAT HE HELD FOR TISSUE COMPRESSION. THEY OPENED A NEW STAPLER TO COMPLETE THE PROCEDURE. NO HARM OR DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735815 ↗
• InjuryFeb 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLAMP WAS PLACED AND THE STAPLER WAS FIRED. THE OPERATOR THEN PERFORMED A TRANSECTION USING THE COLD BLADE AT THE HIGH RECTAL LEVEL. WHEN THE CLAMP WAS OPENED, IT WAS FOUND THAT THERE WERE NO STAPLES IN THE CARTRIDGE. THE RECTUM THEN ENDED UP OPEN INTO THE ABDOMINAL CAVITY. THE SURGEON HAD TO PERFORM A LOWER TRANSECTION AT THE MID-RECTAL LEVEL. AS A CONSEQUENCE, THE PATIENT REQUIRED THE CREATION OF A PROTECTIVE ILEOSTOMY, WHICH HAD NOT BEEN PLANNED IN THE INITIAL OPERATIVE STRATEGY. A DIFFERENT TX60G CLAMP WAS THEN USED TO TRANSECT THE MID-RECTUM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24401741 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE THE STAPLER PAPER FELT TOO THIN AND RIPPED EASILY - SEEMED TO NOT HAVE INTEGRITY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260778 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLON RESECTION THAT THE TX WAS APPLIED TO THE BOWEL AND FIRED. WHEN THE STAPLED AREA WAS EXAMINED, NONE OF THE STAPLES WERE FORMED PROPERLY. THE MAJORITY OF THE STAPLE LEGS WERE STRAIGHT WITH ONLY A FEW THAT WERE FORMED IN A C SHAPE. STAPLE LINE WAS OVERSEWN. PROCEDURE WAS DELAYED BY 25 MINUTES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336385 ↗
• MalfunctionSep 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES DID NOT FULLY CLOSE. THE DOCTOR WANTED TO STAPLE THE COLON AND NOT ALL THE STAPLES WENT THROUGH AND CLOSED PROPERLY. THEY PROCEEDED TO USE REGULAR SUTURES TO MAKE SOME POINTS. THEY INCLUDED SOME OF THE STAPLES AS PROOF THAT THEY WERE MALFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23003233 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH HISTORY OF COPD, CORONARY ARTERY DISEASE, OBESITY AND SURGICALLY TREATED PROSTATE CANCER WHO UNDERWENT RIGHT HEMICOLECTOMY, INCISIONAL HERNIA REPAIR, AND PARTIAL OMENTECTOMY TO TREAT CECAL AND ASCENDING COLON CANCER. OPERATIVE NOTE INDICATES MASS WAS JUST PROXIMAL TO THE CECUM AND THE ASCENDING COLON AND THE RIGHT COLON WAS MOBILIZED TO THE LEVEL OF THE HEPATIC FLEXURE. THE ILEUM WAS ALSO MOBILIZED GIVEN EXTENSIVE ADHESIONS. ¿LIGASURE¿ WAS USED TO TRANSECT TO DIVIDE THE RIGHT COLON AND A ¿75MM GIA STAPLER¿ WAS USED TO TRANSECT THE ILEUM AND MID TRANSVERSE COLON AND TO CREATE THE ANASTOMOSIS. A ¿TX60¿ WAS USED TO CLOSE THE ENTEROTOMY SITES. NO DIFFICULTIES WERE NOTED WITH ANY STAPLERS. 4 DAYS POST-OPERATIVELY, THE PATIENT SHOWED SIGNS OF LEAK AND UNDERWENT AN EXPLORATORY LAPAROTOMY WITH CREATION OF ILEOSTOMY AND DRAINAGE OF INTRA-ABDOMINAL ABSCESS. OPERATIVE NOTE INDICATES A ¿4 MM AREA OF DEHISCENCE OF BOWEL CONSISTENT WITH THE SITE OF HIS ANASTOMOTIC LEAK.¿ AN ILEOSTOMY WAS CREATED AND PATIENT WAS DISCHARGED ONE WEEK LATER. 10 DAYS FOLLOWING DISCHARGE, HE PRESENTED WITH A LEAKING STOMA. POST-OPERATIVELY, THE PATIENT¿S ILEOSTOMY HAD BECOME

  Patient problems: Abscess; Adhesion(s); Failure to Anastomose; Hernia; Necrosis

  MAUDE report 22439856 ↗
• MalfunctionApr 2, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION THE PACKAGING TORE IN 2 LOCATIONS WHEN THE RN OPENED THE DEVICE. PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751345 ↗
• MalfunctionMar 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CHARGER PRESENT ON THE CLAMP DID NOT WORK DURING STAPLING. OPENING A NEW CHARGER FROM AN INDIVIDUAL PACKAGE. NO PATIENT CONSEQUENCE. THE TRIGGER ADVANCEDBUT NO STAPLES WERE DEPLOYED ON THE DIGESTIVE TUBE. AND ONCE THE LOADER WAS REMOVED FROM THE CLAMP THERE WERE B-SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535492 ↗
• InjuryNov 26, 2024Failure to Cut; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Firing Problem; Failure to Cut; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Firing Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THAT PRIOR TO CLOSURE THE LEAK TEST WAS PREFORMED AND A LEAK WAS FOUND. ON THE ATTEMPT TO FIX THE LEAK THE SURGEON WENT DISTAL TO THE FIRST STAPLE LINE WITH THE TX60B BUT THE STAPLER WAS DIFFICULT TO CLOSE AND IT MAKES A FUNNY NOISE. THE SURGEON "FORCED" IT TO FIRE AND WHEN EXAMINED, NO STAPLES HAD BEEN DEPLOYED AND THE KNIFE DID NOT CUT. A SECOND TX60B WAS OPENED. A SECOND LEAK TEST WAS DONE AND NO LEAK WAS DETECTED. THE SURGEON WAS NOT COMFORTABLE WITH THE OUTCOME SO ERRING ON THE SIDE OF CAUTION AND DID A DIVERSION AND CREATED AN ILEOSTOMY. THE PATIENT WILL RETURN IN THREE TO SIX MONTHS TO HAVE THE STOMA CLOSED.

  Patient problems: Failure to Anastomose

  MAUDE report 20777976 ↗
• InjuryOct 31, 2024Failure 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 POST OP OF A ROBOTIC SIGMOID COLECTOMY PROCEDURE THAT THE PATIENT WAS BROUGHT BACK TO THE OR DUE TO A HOLE IN THE STAPLE LINE. THE HOLE WAS REPAIRED WITH SUTURE AND A DRAIN WAS PLACED. PATIENT CURRENT STATUS UNKNOWN BUT PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20577276 ↗
• MalfunctionSep 24, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PART RESECTION FOR THE SMALL INTESTINE, THEY USED THE TX60B, BUT THE STAPLE LINE WAS NOT COMPLETE. THEY TOOK ANOTHER XR60B RELOAD WITH THE SAME RESULT. THEY OPEN ANOTHER TX60B AND THEY FINISHED THE OPERATION WITHOUT ANY PROBLEMS. THE PATIENT SUFFERED NO HARM!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291150 ↗
• MalfunctionSep 4, 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 THE PACKAGING/TYVEK TORE UNEVENLY COMPROMISING STERILITY ON TX60B. 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 20135210 ↗
• MalfunctionSep 3, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SIGMOIDOSCOPY PROCEDURE, DOCTOR FIRED STAPLER TO CLOSE AND NO STAPLES CAME OUT. UPON OPENING THE STAPLER THEY SAW THAT NO STAPLES HAD FIRED. OPENED ANOTHER STAPLER TO COMPLETE CASE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127656 ↗
• MalfunctionAug 22, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE WAS MALFORMED AFTER FIRING.THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035128 ↗
• MalfunctionAug 8, 2024Failure to Form Staple; Insufficient Device Problem Information; Failure to Form Staple; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE TX60G STAPLES DIDN'T DEPLOY PROPERLY. SURGEON HAD TO TAKE ANOTHER TX TO COMPLETE THE CASE. BOWEL INJURY WAS REPORTED, BUT NOT ELABORATED. OPENED ANOTHER TX60 DEVICE TO COMPLETE THE CASE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19941594 ↗
• MalfunctionJul 19, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND AFTER FIRING, STAPLES WAS NOT FORMED WELL ON TISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19782051 ↗
• InjuryJun 25, 2024Failure to Fire; Failure to Fire

  SEE ATTACHED MW (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19605649 ↗
• MalfunctionMar 29, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOOP ILEOSTOMY CLOSURE, SURGEON FIRED THE DEVICE AND NO STAPLES PRESENTED FROM THE PROXIMAL/BOTTOM END OF THE JAW. THEREFORE THE OSTOMY REMAINED PARTIALLY OPEN. SURGEON RECOGNIZED IMMEDIATELY UPON EXAMINING THE STAPLE LINE AND OVERSEWED THE TISSUE TO COMPLETE THE CLOSURE. THE SURGERY WAS DELAYED 2 MINUTES. SEWED THE REMAINING TISSUE CLOSED WITH SUTURE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002810 ↗
• InjuryJan 19, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLECTOMY THE TX 60B DID NOT FIRE OUT STAPLES. PATIENT REQUIRED A COLOSTOMY BAG. THERE WAS A 20 MINUTE DELAY FROM THE RESULT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18546166 ↗