PROXIMATE TVC55Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705036013389), received between Nov 15, 2021 and Apr 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT SURGEON PLACED STAY STITCHES TO TEMPORARILY CLOSE THE GASTROCUTANEOUS FISTULA IN ORDER TO PLACE THE STAPLER ACROSS THE GASTRIC TISSUE. SHE THEN PLACED THE STAPLER ACROSS THE TISSUE AND FIRED. THE STAPLER FIRED BUT THE SURGEON NOTICED IT WAS A LITTLE DIFFICULT TO SLIDE THE FIRING KNOB BACK AFTER IT WAS FIRED AND BEFORE OPENING THE DEVICE. ONCE THE DEVICE WAS REMOVED FROM THE TISSUE, SHE NOTICED STAPLES FORMED CORRECTLY ON ONLY THE PROXIMAL 1/3RD OF THE STAPLE LINE. THE REMAINING 2/3RDS OF THE TISSUE DID NOT HAVE ANY STAPLES AND THE TISSUE WAS STILL OPEN. SHE THEN USED VICRYL SUTURES TO CLOSE THE REMAINING PORTION OF THE TISSUE TO COMPLETE THE CASE. SURGICAL DELAY UNKNOWN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873341 ↗
• MalfunctionJan 18, 2024

  VASCULAR GIA STAPLING DEVICE WAS THEN USED TO COME ACROSS THE FISTULA FROM THE LATERAL SIDE, BUT IT CLEARLY FULLY MISFIRED--WHEN HAD COULD CUT ACROSS ONLY APPROXIMATELY HALF OF THE TRACT WITH THE STAPLER BECAME LOCKED UP. AS SUCH, THE STAPLER WAS DISENGAGED. WE THEN USED A COMPLETELY NEW VASCULAR GIA STAPLER DEVICE WITH A NEW LOAD OF STAPLES, AND THIS TIME TRIED TO USE THAT STAPLER COMING FROM THE MEDIAL SIDE. WE WAITED AT LEAST 30 SECONDS PRIOR TO FIRING THE STAPLER AS WE HAD WITH THE FIRST STAPLER, AND AGAIN WHEN TRYING TO COMPLETE THE CUT WITH THE STAPLER, THE MECHANISMS SIMPLY WOULD NOT ADVANCE AFTER THE STAPLER HAD CUT ACROSS APPROXIMATELY HALF THE WIDTH OF THE FISTULA TRACT TISSUES ON THE MEDIAL SIDE. AS SUCH, THAT STAPLER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535465 ↗
• MalfunctionSep 11, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING THE FISTULA PROCEDURE THIS CASE WAS ON A PEDIATRIC PATIENT AND THE FISTULA WAS THIN TISSUE. SURGEON FIRED THE TVC55 ACROSS THE GASTROCUTANEOUS FISTULA. ABOUT HALFWAY THRU THE FIRING SEQUENCE, THE STAPLER LOCKED OUT. THE SURGEON SLID THE FIRING KNOB BACK AND RELEASED THE DEVICE FROM THE TISSUE. FORMED STAPLES WERE NOTED BUT NOT ON BOTH SIDES OF THE CUT LINE. THEY RELEASED THE STAPLER FROM THE TISSUE AND SUCCESSFULLY COMPLETED THE CASE WITH CLAMPS, SCISSORS, AND SUTURES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720676 ↗
• MalfunctionJun 22, 2022Failure to Fire; Failure to Fire

  SEE ATTACHED USER FACILITY MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775668 ↗
• MalfunctionJun 3, 2022Failure to Form Staple

  STAPLER FIRED BUT STAPLE LINE OF ANATOMY NOT INTACT, NO STAPLES ON LINE OF ANATOMY LIKE THERE SHOULD BE, STAPLE LINE HAD TO BE SEWN CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14591865 ↗
• MalfunctionNov 15, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING HEMORRHOIDECTOMY THE DEVICE BLOCKED INTRAOPERATIVELY AND DID NOT TRIGGER. AN ADDITIONAL DEVICE WAS OPENED AND THE OP ENDED WITH NO INFLUENCE ON SURGERY AND PAT. SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815625 ↗