Proximate TCD75Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036013112), received between Dec 10, 2020 and Dec 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Failure to Fire; Material Integrity Problem; Failure to Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING RADICAL RESECTION OF RIGHT COLON CANCER SURGERY, COULD NOT FIRE. 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 12919453 ↗
• MalfunctionDec 10, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE NURSE OPENED THE PAPER BOX AND TOOK OUT THE INNER PACKAGE, THE STAPLER WAS WRONGLY POSITIONED INSIDE THE INNER PACKAGE, DIAGONALLY AND TIP OF THE INSTRUMENT WAS SEALED BETWEEN THE PAPER AND PLASTIC SEALING SO THAT DISTAL TIP OF THE INSTRUMENT WAS SEEN AND PACKAGE WAS NOT STERILE ANYMORE. CURRENTLY THE PACKAGE IS A BIT MORE OPENED THEN IT WAS IN THE BEGINNING, BECAUSE NURSE OPENED IT A BIT MORE. SO- THE SUMMARY OF THE PROBLEM WAS THAT INSTRUMENT ARRIVED AS NON-STERILE BECAUSE ONE CORNER WAS NOT SEALED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984296 ↗