SMART TSF 71078550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556746073), received between Dec 3, 2021 and Apr 16, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionApr 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING SURGERY, A SMART TSF CONVERSION CLAMPS BROKE OUTSIDE THE PATIENT AS IT WAS BEING TIGHTENED ON TSF RING. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM ((B)(4)) THREE ADDITIONAL CLAMPS WERE RECEIVED, BUT IT IS UNSPECIFIED WHAT THEIR FAILURES ARE ((B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131669 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A SMART TSF CONVERSION CLAMP BROKE OUTSIDE THE PATIENT AS IT WAS BEING TIGHTENED ON TSF RING. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929353 ↗