Proximate TCT10Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036003052), received between Oct 5, 2018 and Apr 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE STAPLER GUN DID NOT FIRE WELL; FIRED IN OPPOSITE DIRECTION RESULTING IN SPIKED ENDS. NO ADVERSE ISSUES FOR THE PATIENT. THIS ISSUE WAS NOTICED BY THE SURGEONS, AND THE STAPLES WERE SUBSEQUENTLY REMOVED. A NEW STAPLER GUN WAS USED WHICH WAS FINE TO COMPLETE THE RESECTION. NO HARM TO PATIENT HOWEVER IT DELAYED PROCEDURE FOR ABOUT 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872102 ↗
• MalfunctionSep 14, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A HYSTERECTOMY AND ON THE TRANSACTION ON SMALL BOWEL AND COLON, SURGEON NOTICED THAT THE DISTAL PART OF STAPLE DIDN'T FORM AND STAPLE ON THE SPECIMEN AS PICTURE ATTACHED. SURGEON TOLD THAT HE FIRED ALL THE WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744503 ↗
• MalfunctionJul 20, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AFTER FIRING, STAPLES DIDN'T CLOSE PROPERLY TO APPROXIMATE WOUND. ANOTHER RELOAD WAS USED TO FINISH SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364983 ↗
• MalfunctionMay 8, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DISTAL GASTRECTOMY, KNIFE DID NOT MOVE FORWARD AT 1ST FIRING. THE CARTRIDGE COLOR WAS GREEN. THERE IS A POSSIBILITY THAT THE STOMACH HAS BEEN ENLARGED DUE TO CHEMOTHERAPY. 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 16890436 ↗
• MalfunctionJan 10, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AFTER THE DEVICE WAS FIRED, THE STAPLE LEG DIDN'T MAKE A FULL B SHAPE. RETRIEVED RELOAD AND AS MUCH AS STAPLES AS POSSIBLE, HAND SUTURED CUT SITE AND FINISHED SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132590 ↗
• MalfunctionJan 9, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT ONLY 4 STAPLES DEPLOYED, AND THE REST DID NOT. TO COMPLETE THE TRANS-SECTION, THE STAFF OPENED ANOTHER PROXIMATE LINEAR STAPLER WHICH WAS FUNCTIONING FINE. THERE WAS NO PATIENT INJURY, NO DELAY TO OR TIME, AND NO IMPACT TO THE TEAM/THEATRE ENVIRONMENT. THE SURGEON IS VERY FAMILIAR WITH OUR PRODUCT AND A REGULAR USER OF THIS PRODUCT (PER CLINICAL STAFF ADVISE). PROCEDURE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124544 ↗
• MalfunctionJan 27, 2022Material Integrity Problem; Mechanical Jam; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING A RIGHT COLECTOMY PROCEDURE, RELOAD OF THE DEVICE BROKE. ANOTHER RELOAD WAS PUT IN AND THE BUTTON TO FIRE DEVICE WOULD NOT MOVE FORWARD. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368763 ↗
• MalfunctionOct 5, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SOME STAPLES DID NOT FORM PERFECT B SHAPE SO THE SURGEON HAD TO DO REINFORCE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939187 ↗
• MalfunctionOct 5, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SOME STAPLES DID NOT FORM PERFECT B SHAPE SO THE SURGEON HAD TO DO REINFORCE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939182 ↗