PROXIMATE TX60GRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10705036003359), received between Dec 14, 2017 and Apr 21, 2026 — classified as 6 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (17 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE, PACKAGE HAD BROKEN BEFORE OPEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943116 ↗
• MalfunctionMar 16, 2026Delivered as Unsterile Product

  IT WAS REPORTED PRIOR TO PARTIAL ESOPHAGECTOMY PROCEDURE THE CIRCULATING NURSE OPENED THE STERILE PACKAGING AND OBSERVED THAT THE PACKAGE WAS IMPROPERLY SEALED. AS A RESULT, THE DEVICE WAS CONSIDERED NON-STERILE DUE TO THE PACKAGING DEFECT. THE ISSUE WAS IDENTIFIED PRIOR TO USE, AND THE DEVICE WAS NOT INTRODUCED INTO THE STERILE FIELD. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24610515 ↗
• MalfunctionJun 12, 2025Failure to Form Staple; Failure to Fire; Insufficient Device Problem Information; Failure to Form Staple; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PATIENT IS FOLLOWED-UP FOR THE RECURRENCE OF PERITONEAL CARCINOMATOSIS OF COLONIC ORIGIN, MANAGED THROUGH RESECTION OF THE ANASTOMOSIS BETWEEN THE SMALL INTESTINE AND THE SIGMOID COLON. THE SURGICAL INTERVENTION ALSO INVOLVED SUPRAMESOCOLIC OMENTECTOMY, RESECTION OF THE SUSPENSORY LIGAMENT OF THE LIVER, EXCISION OF THE SMALL OMENTUM, AND REMOVAL OF A LEFT PERIURETERAL NODULE FOLLOWING LEFT URETEROLYSIS, IN ADDITION TO PRE-VESICAL PERITONECTOMY. HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) WAS ADMINISTERED DURING THE SURGERY. DURING THE PROCEDURE, THE SURGEONS IDENTIFIED A STENOSIS OF THE COLORECTAL ANASTOMOSIS, WHICH NECESSITATED EXTENDING THE RESECTION TOWARDS THE RECTUM TO POSITION THEMSELVES BENEATH THE ANASTOMOSIS. WHILE STAPLING THE COLON, THE MECHANICAL CLAMP DID NOT FUNCTION CORRECTLY 3 TIMES. A DIFFERENT CLAMP OF THE SAME REFERENCE BUT FROM DIFFERENT LOT WAS EMPLOYED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 22193069 ↗
• MalfunctionMay 19, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE FIRED THE STAPLES BUT DID NOT CUT THEREAFTER. DEFECTIVE DEVICE NO LONGER USED. ALTERNATIVE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044699 ↗
• MalfunctionMay 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN USING THE DEVICE, THE STAPLER DOES NOT WANT TO STAPLE PARTS OF THE COLON. CONSEQUENTLY, USING ANOTHER DEVICE OF THE SAME REFERENCE, THE PROCEDURE COULD BE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008422 ↗
• MalfunctionMay 7, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLON CASE, THE DEVICE DID NOT DEPLOY THE STAPLES. CASE WAS COMPLETED BY SUTURING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975712 ↗
• MalfunctionOct 15, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONE OF THE ROWS OF STAPLES DID NOT FIRE. IT APPEARS THAT ALL THE DRIVERS HAVE DEPLOYED. NO FURTHER DETAILS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457048 ↗
• MalfunctionMay 7, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT DID NOT STAPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259724 ↗
• MalfunctionDec 12, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A KOCH POUCH CONTINENT ILEOSTOMY PROCEDURE THAT WHEN THE SURGEON FIRED THE STAPLER THE STAPLES DID NOT FORM AND WERE LEFT IN THE "GOAL POST" SHAPE. STAPLER WAS RELOADED WITH A NEW CARTRIDGE AND FIRED AGAIN OVER THE SAME TISSUE. STAPLER FIRED CORRECTLY BUT SURGEON OVER SEWED THE STAPLE LINE FOR REASSURANCE. LATER IN THE PROCEDURE A SECOND STAPLER WAS OPENED AND ON THE FIRST FIRING ATTEMPT THE STAPLES DID FORM AND WERE LEFT IN THE "GOAL POST" SHAPE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. STAPLER WAS RELOADED WITH A NEW CARTRIDGE AND FIRED AGAIN OVER THE SAME TISSUE. STAPLER FIRED CORRECTLY BUT AGAIN THE SURGEON OVER SEWED THE STAPLE LINE FOR REASSURANCE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310197 ↗
• MalfunctionDec 12, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A KOCH POUCH CONTINENT ILEOSTOMY PROCEDURE THAT WHEN THE SURGEON FIRED THE STAPLER THE STAPLES DID NOT FORM AND WERE LEFT IN THE "GOAL POST" SHAPE. STAPLER WAS RELOADED WITH A NEW CARTRIDGE AND FIRED AGAIN OVER THE SAME TISSUE. STAPLER FIRED CORRECTLY BUT SURGEON OVER SEWED THE STAPLE LINE FOR REASSURANCE. LATER IN THE PROCEDURE A SECOND STAPLER WAS OPENED AND ON THE FIRST FIRING ATTEMPT THE STAPLES DID FORM AND WERE LEFT IN THE "GOAL POST" SHAPE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. STAPLER WAS RELOADED WITH A NEW CARTRIDGE AND FIRED AGAIN OVER THE SAME TISSUE. STAPLER FIRED CORRECTLY BUT AGAIN THE SURGEON OVER SEWED THE STAPLE LINE FOR REASSURANCE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310190 ↗
• InjuryJul 24, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS USED AND WHEN THEY FIRED IT NONE OF THE STAPLES CRIMPED THEY CAME OUT IN THEIR ORIGINAL STATE. THE PROCEDURE HAD TO BE REVERTED TO OPEN.

  Patient problems: Insufficient Information

  MAUDE report 17382073 ↗
• MalfunctionJun 27, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAP ANTERIOR RESECTION THE SURGEON USED THE TX60G ON THE BOWEL TO STAPLE. HE CLOSED THE DEVICE, SQUEEZED THE HANDLE AND WHEN HE OPENED THE DEVICE THE STAPLES WERE NOT FORMED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208491 ↗
• MalfunctionJun 13, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE AS FIRED ON COMMON OTOMY OF LARGE COLON. SURGEON NOTED THERE WERE NO STAPLES IN TISSUE ON THE PORTION OF THE STAPLE LINE PROXIMAL TO THE DEVICE METAL HOUSING (DISTAL TO THE TISSUE RETENTION PIN) WHERE IT CONNECTS TO THE STAPLER. A SECOND DEVICE WAS FIRED ON THE OPEN PORTION AND OVERSEWN. NO PATIENT CONSEQUENCE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117806 ↗
• MalfunctionFeb 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER FAILED TO FIRE STAPLES. LIKE, THERE WAS NO STAPLES INSIDE CARTRIDGE. THERE WERE NO STAPLES SEEN IN THE SURGICAL FIELD. THERE WAS NO DELAY TO THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351396 ↗
• MalfunctionSep 20, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE ANASTOMOSIS PROCEDURE, WHEN THEY FIRED THE STAPLES, THEY DIDN'T DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454564 ↗
• MalfunctionJul 28, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLORECTAL SURGERY THE TX60G STAPLER WAS USED AND IT COULD NOT PROPERLY CLOSE THE CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125158 ↗
• MalfunctionApr 28, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT AFTER THE RELEASE, THE DEVICE COULD NO LONGER BE OPENED. QUITE A BIT OF FORCE WAS USED WHEN TRYING TO OPEN IT. WHEN THE SURGEON OPENED IT, THE RETAINING PIN FROM THE MAGAZINE DIDN¿T GO BACK. IT WAS THEN PREPARED OUT. NO PATIENT HARM REPORTED. PROCEDURE: LOWER LOBE RESECTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240372 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS USED TO CLOSE THE ANASTOMOSIS BROWN (SIDE INTESTINE ANASTOMOSIS). THE PATIENT PRESENTED LEAKAGE FROM THE APPLICATION POINT ON THE 4TH TO 6TH POST-OPERATIVE DAY. PROCEDURE: GASTRECTOMY.

  Patient problems: Failure to Anastomose

  MAUDE report 12288247 ↗
• MalfunctionAug 2, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN PNEUMECTOMY, WHEN BRONCHUS WAS SET DOWN THE INSTRUMENT DID NOT STAPLE, ALL STAPLES WERE UNFORMED. A HAND ANASTOMOSIS WAS DONE. NO FURTHER CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259239 ↗
• MalfunctionApr 12, 2021Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED STAPLER WAS USED WITH RELOADS X2 FOR ILEOCOLIC RESECTION PROCEDURE. BOTH FIRINGS FAILED TO ACHIEVE OPTIMAL CLOSURE OF ILEOCOLIC TISSUE. SEEMS AS IF STAPLER DID NOT CLOSE EVENLY ALONG THE CARTRIDGE, RESULTING IN LEAKAGE ON ONE END OF TISSUE. MORE TISSUE RESECTED TO TRY AGAIN BUT RESULTED IN LEAKAGE AGAIN. ALTERNATIVE STAPLERS REQUESTED AND USED TO COMPLETE RESECTION SUCCESSFULLY. THE SURGERY WAS DELAYED BY 1-HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648072 ↗
• MalfunctionJan 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY WITH A RESECTION OF THE TRANSVERSE COLON PROCEDURE THAT SURGEON WENT TO STAPLE THE DISTAL COLON. SURGEON THEN CUT THE COLON WITH A SCALPEL. WHEN THE SURGEON OPENED THE STAPLER THERE WERE NO STAPLES AND THE COLON WAS OPEN. ANOTHER STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133722 ↗
• MalfunctionJan 4, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, OPENED STERILE TX60G TO USE STAPLER ON RECTUM IN ANTERIOR RESECTION PROCEDURE. SURGEON FOUND THAT THE RETAINING PIN COULD NOT PUSH TO CLOSE IT, THE RETAINING PIN BOUNCE BACK TO THE ORIGINAL POSITION. SURGEON TRIED TO CLOSE THE CLOSING HANDLE BUT FAILED TO CLOSE. ENDED OPEN COMPETITIVE DEVICE BECAUSE THAT IS THE LAST PIECE OF AVAILABLE TX60G IN OT. THE STAFF NURSE PASS THE TX60G TO ME AFTER WASH. AFTER TRYING FOR A FEW TIMES, THE RETAINING PIN & CLOSING HANDLE CAN CLOSE AND ABLE TO FIRE. THEREFORE, YOU MAY SEE SOME PART OF THE STAPLER HAS STAPLER. THE SURGERY WAS DELAYED BY 15-MINUTES AND SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11107957 ↗
• MalfunctionDec 10, 2020Failure to Fire; Failure to Fire

  THERE WERE NO STAPLES IN THE MAGAZINE, SO THE DEVICE DID NOT STAPLE. A NEW MAGAZINE HAD TO BE OPENED. PROCEDURE FINISHED SUCCESSFULLY WITH NO PATIENT HARM NOR SIGNIFICANT SURGICAL DELAY. PROCEDURE: VATS, DECORICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988723 ↗
• MalfunctionOct 29, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PACKAGING WAS DEFECTIVE : THE BLISTER DIVIDED IN TWO. THE DEVICE HAS NOT BEEN USED BECAUSE DOUBT ABOUT STERILITY. THIS WAS IDENTIFIED AT THE BEGINNING BEFORE USE OF PRODUCT. THERE WERE NO ISSUES WITH OPENING AS THE BLISTER WAS SPLIT. THE STERILITY WAS COMPROMISED. THERE WERE NO PATIENT CONSEQUENCES AS ANOTHER DEVICE WAS USED.

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

  MAUDE report 10755021 ↗
• MalfunctionSep 23, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PARTIAL FIRING OF STAPLES. INFORMATION PROVIDED IS THAT RESIDENT FIRED DEVICE AND MAY BE USER ERROR NOT GOING PLASTIC TO PLASTIC. OVERSEW OF STAPLE LIKE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES OR CHANGE OF POST-OPERATIVE CARE. PROCEDURE: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574792 ↗