PROXIMATE TX30GRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705036003328), received between Apr 24, 2018 and Jan 20, 2026 — classified as 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A THORACOTOMY, IT WAS OBSERVED THAT THE LID OF THE PACKAGING OF THE DEVICE WAS TORN DURING ITS UNPACKING, MAKING IT IMPOSSIBLE TO GRASP STERILE. THIS INCIDENT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT BUT RESULTED IN AN ADDITIONAL COST FOR THE INSTITUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116112 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A THORACOTOMY, IT WAS OBSERVED THAT THE LID OF THE PACKAGING OF THE DEVICE WAS TORN DURING ITS UNPACKING, MAKING IT IMPOSSIBLE TO GRASP STERILE. THIS INCIDENT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT BUT RESULTED IN AN ADDITIONAL COST FOR THE INSTITUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115960 ↗
• MalfunctionMay 27, 2025Failure to Cut; Failure to Fire; Firing Problem; Failure to Cut; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER WAS PLACED IN PLACE AND THE 1ST HANDLE WAS PRESSED. THERE WAS A LOT OF RESISTANCE WHEN THE 2ND HANDLE WAS RELEASED. WE MANAGED TO PRESS DOWN AND THE SEAM SEEMED TO HAVE BEEN RELEASED. HOWEVER, AFTER REMOVING THE DEVICE, THERE WAS NO SEAM. A 2ND STAPLER WAS NEEDED TO MAKE THE SEAM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086837 ↗
• MalfunctionFeb 20, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A HARTMAN PROCEDURE THE DR USED A TX30G FOR TISSUE TRANSECTION. SHE FIRST PRESSED ON THE CLOSING TRIGGER TO INSERT THE PIN AND CLOSE THE JAW. THEN SHE PRESSED ON FIRING TRIGGER TO FIRE THE STAPLER, BUT NO STAPLES CAME OUT. THE FIRING TRIGGER IS CLOSED AND DID NOT BOUNCE BACK TO THE ORIGINAL POSITION. SHE TRIED TO OPEN THE JAW BY PRESSING THE RELEASE BUTTON BUT THE JAWS WERE STILL CLOSED. SHE FINALLY PULLED THE FIRING TRIGGER BACK TO THE ORIGINAL POSITION TO OPEN THE JAWS. THE STAPLES ON THE TX30G WERE FIRED AFTER THE CASE, WHEN DR WERE EXAMINING IT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425793 ↗
• MalfunctionAug 13, 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 THE PACKAGING WAS OPENED, THE PAPER IMMEDIATELY PULLED OPEN IN AN UNUSUAL MANNER TO UNSTERILIZED THE DEVICE. ANOTHER DEVICE WAS USED. THE ISSUE WAS NOTICED AT THE OPENING OF THE BLISTER OF THE IMPACTED DEVICE. THE PAPER PART WAS BADLY TORN/PEELED AND COMPROMISED THE STERILITY OF THE DEVICE. NO PATIENT CONSEQUENCE. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PICTURE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973159 ↗
• MalfunctionAug 13, 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 THE PACKAGING WAS OPENED, THE PAPER IMMEDIATELY PULLED OPEN IN AN UNUSUAL MANNER TO UNSTERILIZED THE DEVICE. ANOTHER DEVICE WAS USED. NO SPECIFIC CONSEQUENCE. THE ISSUE WAS NOTICED AT THE OPENING OF THE BLISTER OF THE IMPACTED DEVICE. THE PAPER PART WAS BADLY TORN/PEELED AND COMPROMISED THE STERILITY OF THE DEVICE. NO PATIENT CONSEQUENCE. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PICTURE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973063 ↗
• MalfunctionJun 20, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT HALF THE STAPLES ARE STUCK IN THE GUN, THEY DIDN'T USE A RELOAD AS THE SURGEON WASN'T HAPPY SO THEY USED AN ALTERNATIVE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576156 ↗
• MalfunctionJun 13, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLE SUTURE ON THE BRONCHUS ONLY RELEASED HALFWAY AND COULD THEN NO LONGER BE OPENED EASILY. UNFORTUNATELY, THE CUSTOMER DISCARDED THE INSTRUMENT. NO PATIENT HARM OR SURGERY DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531544 ↗
• MalfunctionMay 9, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LUNG TRANSPLANT PROCEDURE THAT THE DEVICE FAILED. ONCE LOCKED ON TISSUE THE DEVICE WOULD NOT OPEN, FORCED TO MANUALLY OPEN THE STAPLER. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280448 ↗
• MalfunctionOct 31, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO 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 18040844 ↗
• MalfunctionOct 19, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN RECTUM RESECTION, THE DEVICE WAS FIRED, BUT THE STAPLE COULD NOT BE DEPLOYED. THE SURGEON DID NOT NOTICE ABOUT THAT AND CUT THE RECTUM BY THE KNIFE. THE STAPLE WAS NOT LEFT ON THE TARGET TISSUE, SO THE TISSUE WAS PULLED FROM THE ANUS SIDE AND THE PURSE SUTURING WAS PERFORMED AND SST ANASTOMOSIS WAS PERFORMED. THE OPERATION WAS CHANGED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967546 ↗
• MalfunctionJul 19, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAP GASTRECTOMY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 17350103 ↗
• MalfunctionJul 19, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAP GASTRECTOMY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 17350086 ↗
• MalfunctionApr 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN ANTERIOR RESECTION, STAPLE COULD NOT BE DEPLOYED. THE SURGEON FIRED WITH THE STRONG FORCE. THE DEVICE WAS USED ON THE RECTUM. 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 16707370 ↗
• MalfunctionFeb 10, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN ANTERIOR RESECTION, THE JAWS DID NOT OPEN AFTER 2ND FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO CHANGE IN PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350715 ↗
• MalfunctionJan 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A THORACOTOMY/ OPEN LEFT LOWER LOBECTOMY THE STAPLER MALFUNCTIONED. THE STAPLES NEVER RELEASED WHEN FIRED CREATING OPEN ARTERY INTO PLURAL SPACE. THIS REQUIRED MORE HOURS FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16130661 ↗
• MalfunctionJul 15, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON FIRED THE DEVICE AND THEN WENT TO MANUALLY CUT. REMOVED THE DEVICE TO FIND THE STAPLES HADN¿T BEEN DEPLOYED SO BRONCHUS WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029307 ↗
• MalfunctionFeb 11, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE SURGEON TRIED TO USE THE TX30G DEVICE TO PERFORM THE DISTAL TRANSECTION AT THE SIGMOID COLON TO REMOVE A TUMOR DURING A LOW ANTERIOR RESECTION CASE. SURGEON IS A SENIOR SURGEON WITH MANY YEARS OF EXPERIENCE OF USING THE TX30G DEVICE. THE TISSUE WAS PLACED COMFORTABLY WITHIN THE JAWS OF THE DEVICE, AND THE DEVICE WAS THEN CLOSED AND FIRED. HOWEVER, THE TWO ROWS OF STAPLES WERE NOT FORMED AND THERE WAS NO EVIDENCE OF THE STAPLES EVEN BEING PRESENT IN THE STAPLE HOUSING. SURGEON THEN PROCEEDED TO USE SUTURES INSTEAD TO COMPLETE THE DISTAL TRANSECTION. THE CASE WAS DELAYED BY 90-MINUTES. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO FRAGMENTS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514158 ↗
• MalfunctionFeb 9, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE SURGEON TRIED TO USE THE TX30G DEVICE TO PERFORM THE DISTAL TRANSECTION AT THE SIGMOID COLON TO REMOVE A TUMOR DURING A LOW ANTERIOR RESECTION CASE. SURGEON IS A SENIOR SURGEON WITH MANY YEARS OF EXPERIENCE OF USING THE TX30G DEVICE. THE TISSUE WAS PLACED COMFORTABLY WITHIN THE JAWS OF THE DEVICE, AND THE DEVICE WAS THEN CLOSED AND FIRED. HOWEVER, THE TWO ROWS OF STAPLES WERE NOT FORMED AND THERE WAS NO EVIDENCE OF THE STAPLES EVEN BEING PRESENT IN THE STAPLE HOUSING. SURGEON THEN PROCEEDED TO USE SUTURES INSTEAD TO COMPLETE THE DISTAL TRANSECTION. THE PROCEDURE WAS DELAYED BY 90-MINUTES AND COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499881 ↗
• MalfunctionNov 17, 2021Delivered 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 PACKAGING RIPPED DUE TO MATERIAL ISSUES AND CONTAMINATED THE STAPLER. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828419 ↗
• MalfunctionOct 7, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION, WHEN USING THE TX30G TO STAPLE ACROSS THE BOWEL IT MISFIRED. THE STAPLER WAS CLOSED. THEY WAITED 15 SECONDS AND PULLED THE FIRING HANDLE, AND IT DID NO FIRE STAPLES. OPENED ANOTHER TX30G AND FIRED WITH NO ISSUES. PATIENT WAS NOT HARMED. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590791 ↗
• MalfunctionAug 26, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, SURGEON USED TX30G TO TRANSECT THE RECTUM. AFTER FIRING WHEN HE OPEN THE STAPLER HE FOUND THAT THE RECTUM IS NOT FIRED. ONLY 10% OF THE STAPLER IS FIRED ON THE RECTUM. SO SURGEON SUTURED THE RECTUM. THE SURGERY WAS DELAYED BY 15-MINUTES AND SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES OR CHANGE IN THE POST-OPERATIVE CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370948 ↗
• MalfunctionMar 15, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN LAR THE STAPLER WAS FIRED BUT NO STAPLERS CAME OUT, DELAYING THE CASE BY 25 MINUTES. HE HAD SEWED TO COMPLETE THE CASE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484562 ↗
• MalfunctionJan 11, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT RESECTING BOWEL AND WHEN USING THE STAPLER, THE DEVICE WAS CLAMPED AROUND THE BOWEL AND BOTH THE CLOSING HANDLE AND FIRING HANDLE WERE PRESSED SIMULTANEOUSLY WHICH CAUSE THE DEVICE TO LOCK. THE GREY RELEASE BUTTON WOULD NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11147446 ↗
• MalfunctionNov 13, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN PNEUMONECTOMY, SOME STAPLES WERE NOT DEPLOYED. 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; No Consequences Or Impact To Patient

  MAUDE report 10838630 ↗