SIGMA 9505-02-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295229285), received between Oct 24, 2018 and Mar 21, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 13840499 ↗
• 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 13840498 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493386 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493380 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257638 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257633 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257630 ↗
• MalfunctionOct 30, 2019Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn; Break; Peeled/Delaminated; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257629 ↗
• MalfunctionOct 24, 2018Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999284 ↗
• MalfunctionOct 24, 2018Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999266 ↗
• MalfunctionOct 24, 2018Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999257 ↗
• MalfunctionOct 24, 2018Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999203 ↗