SIGMA 9505-02-812Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295229407), received between Mar 22, 2018 and Mar 21, 2022 — classified as 6 malfunctions.

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

• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840505 ↗
• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840503 ↗
• MalfunctionJun 3, 2019Peeled/Delaminated; Peeled/Delaminated

  EXAMINATION OF THE SUBMITTED INSTRUMENT CASE CONFIRMED THE BRACKETS ARE DELAMINATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663008 ↗
• MalfunctionMar 22, 2018Delamination; Delamination

  IT WAS REPORTED THAT THE SIGMA TRAY WAS REPLACED DUE TO PEELING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363597 ↗
• MalfunctionMar 22, 2018Delamination; Delamination

  IT WAS REPORTED THAT THE SIGMA TRAY WAS REPLACED DUE TO PEELING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363577 ↗
• MalfunctionMar 22, 2018Delamination; Delamination

  IT WAS REPORTED THAT THE SIGMA TRAY WAS REPLACED DUE TO PEELING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363541 ↗