PROXIMATE TCR55Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705036013129), received between Dec 12, 2017 and Jul 31, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that Postoperatively, a staple line leak was observed. The patient required reoperation, involving the re-transection of the bowel. The anastomosis was re-stapled. The patients stay is extended due to the reoperation. The patient is currently stable.

  Patient problems: Failure to Anastomose

  MAUDE report 50101922 ↗
• InjuryJul 31, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that Postoperatively, a staple line leak was observed. The patient required reoperation, involving the re-transection of the bowel. The anastomosis was re-stapled. The patients stay is extended due to the reoperation. The patient is currently stable.

  Patient problems: Failure to Anastomose

  MAUDE report 50101825 ↗
• MalfunctionDec 2, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, BEFORE STAPLING AND AFTER LOADING THE RELOADS TO THE GUN, STAPLERS PINS WERE LOOSE AND IT WAS FALLING OFF. THE PROCEDURE WAS NOT DELAYED AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693036 ↗
• MalfunctionMar 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 21633597 ↗
• MalfunctionMar 18, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 21633596 ↗
• MalfunctionOct 3, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE WHEN THE TEAM WAS ABOUT TO USE THE DEVICE FOR A CASE, THEY DISCOVERED THAT UPON OPENING THE RELOAD FROM THE STERILE PACKAGING, THE DRIVERS WERE ALREADY VISIBLE. DUE TO PATIENT SAFETY CONCERNS, THEY DECIDED NOT TO USE THE TRC55 ON THE PATIENT. THE SURGERY WAS DELAYED 5 MINUTES. REPLACED THE DEFECTIVE TCR55 WITH ANOTHER TRC55. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360028 ↗
• MalfunctionOct 13, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRECTOMY THE DEVICE DID NOT FIRE AND IT GOT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932103 ↗
• MalfunctionAug 25, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD MISFIRED. STAPLING IS NOT PROPER. THE SURGEON USED SUTURE TO OVER SEW THE STAPLE LINE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628603 ↗
• MalfunctionAug 25, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOADS MISFIRED. STAPLING IS NOT PROPER. THE SURGEON USED SUTURE TO OVER SEW THE STAPLE LINE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628597 ↗
• MalfunctionJun 15, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS MISFIRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139820 ↗
• MalfunctionApr 5, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLUE RELOAD GOT MISFIRED AND DIDN'T WORK. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS DELAYED BY 15-MINUTES AND COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682472 ↗
• MalfunctionJan 31, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, IT WAS FOUND THAT THE STAPLES WERE PROTRUDED BEFORE USE. 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 13399435 ↗
• MalfunctionJan 7, 2022Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SURGEON HAS TAKEN THE STERILE PIECE OF TCR55 AND FOLLOWED ALL NECESSARY FIRING SEQUENCE, BUT STAPLER DID NOT GET FIRED PROPERLY AND HE TOOK ANOTHER NEW STERILE UNIT TO COMPLETE THE OPERATION. THERE WAS NO DELAY TO THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190872 ↗
• MalfunctionNov 11, 2021Failure to Form Staple; Failure to Form Staple

  SURGEON HAS TAKEN THE RELOAD TCR55 AND FOLLOWED ALL THE FIRING SEQUENCE STEPS. BUT THIS RELOAD GOT MISFIRED, SO HE COULD COMPLETE THE PROCEDURE WITH ANOTHER RELOAD. IT IS UNKNOWN WHETHER THE SURGERY WAS DELAYED. THE PROCEDURE WAS COMPLETED BY USING A NEW RELOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799723 ↗
• MalfunctionAug 2, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, CARTRIDGE MISFIRED. THE SURGERY WAS DELAYED BY 15-MINUTES. REMOVED AND REPLACED CARTRIDGE. FRAGMENTS WERE GENERATED BUT REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259592 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TRANSVERSE COLON RESECTION ON (B)(6) 2020 (IS AN ONCOLOGICAL PATIENT) AFTER THAT, THE DOCTOR MADE A COLIC JEJUNUM ANASTOMOSIS (SIDE TO SIDE) WITH A TLC55. ON (B)(6) THE PATIENT WAS RE OPERATED DUE TO VAC THERAPY AND THE SURGEON WAS CHECKING THE PREVIOUS ANASTOMOSIS AND DETECTED A DEHISCENCE/LEAK IN THE STAPLE LINE. THE SURGERY WAS DELAYED BY 30-MINUTES. MANUAL ANASTOMOSIS WAS DONE.

  Patient problems: Failure to Anastomose

  MAUDE report 10987521 ↗
• MalfunctionJan 25, 2019Failure to Form Staple

  IT WAS REPORTED: MALFORMED STAPLES. IT WAS REPORTED THAT DURING THE ESOPHAGECTOMY SURGERY, WHEN SEVERING GASTRIC TISSUE, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8278807 ↗
• MalfunctionDec 12, 2017Failure to Form Staple

  IT WAS REPORTED THAT DURING A SUBTOTAL GASTRECTOMY PROCEDURE. THE DEVICE DIDN'T CLOSE A STAPLE LINE. THE SURGEON WHO USED THE PRODUCT STATED THAT THIS WAS THE FIRST TIME HE CAME ACROSS WITH SUCH A PROBLEM, GENERALLY HE USES THE PRODUCT ALL THE TIME AND HE IS PLEASED WITH THE OUTCOME. HOWEVER, HE ONLY SAW THE ISSUE WITH THIS LOT NUMBERED PRODUCT. THE CLIPS DID NOT GET OUT OF THE CARTRIDGE AND DIDN'T CLOSE THE STAPLE LINE. MEANING, THERE WERE NO LOST CLIPS THROUGH THE STAPLE LINE. THE PROCEDURE WAS COMPLETED BY SUTURING THE OPEN LINE MANUALLY BY THE SURGEON. THERE WAS NO CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7109875 ↗