P.F.C. SIGMA 96-1240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295236238), received between May 7, 2018 and Nov 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021Break; Naturally Worn; Break; Naturally Worn

  THE HOSPITAL IS REPORTING THAT THE PLASTIC IS STARTING TO BREAK AWAY FROM THE TRAILS DUE TO WEAR AND TEAR. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860318 ↗
• MalfunctionNov 23, 2021Break; Naturally Worn; Break; Naturally Worn

  THE HOSPITAL IS REPORTING THAT THE PLASTIC IS TRARTING TO BREAK AWAY FROM THE TRAILS DUE TO WEAR AND TEAR. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860220 ↗
• MalfunctionMay 7, 2018Break; Break

  IT WAS REPORTED THAT ALL 3 INSTRUMENTS WAS BROKE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490278 ↗