Cyclesure 14324Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10705037016211), received between Apr 7, 2017 and May 15, 2020 — classified as 74 malfunctions.

The most frequently reported specific device problem is “Problem with Sterilization” (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. 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 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063559 ↗
• MalfunctionMay 5, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025058 ↗
• MalfunctionApr 30, 2020Problem with Sterilization

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015065 ↗
• MalfunctionApr 30, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE TWO SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014447 ↗
• MalfunctionApr 27, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001864 ↗
• MalfunctionApr 27, 2020Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX FLEX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001858 ↗
• MalfunctionApr 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918980 ↗
• MalfunctionMar 30, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898407 ↗
• MalfunctionMar 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843060 ↗
• MalfunctionMar 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS PARTIALLY RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818853 ↗
• MalfunctionJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE SUBSEQUENT BI RESULTS WERE NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9541230 ↗
• MalfunctionJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE AFFECTED LOAD WAS REPROCESSED PRIOR TO RELEASE EXCEPT ONE ITEM WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9540377 ↗
• MalfunctionDec 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE TWO SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521838 ↗
• MalfunctionDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9399099 ↗
• MalfunctionDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9399030 ↗
• MalfunctionNov 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366195 ↗
• MalfunctionNov 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9366173 ↗
• MalfunctionNov 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9276071 ↗
• MalfunctionNov 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9272866 ↗
• MalfunctionOct 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9215325 ↗
• MalfunctionOct 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199738 ↗
• MalfunctionOct 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199550 ↗
• MalfunctionAug 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100S CYCLE. THE BI WAS INCUBATED FOR 50 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. TWO ITEMS IN THE LOAD WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8918101 ↗
• MalfunctionMay 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® CYCLE. THE AFFECTED LOAD WAS RELEASED AND USED ON A PATIENT. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8651888 ↗
• MalfunctionMay 21, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24.5 HOURS. THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE BOTH NEGATIVE. THE AFFECTED LOAD WAS RELEASED AND USED ON TWO PATIENTS. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS WHEN THE LOAD HAS BEEN RELEASED AND USED ON PATIENT(S) PRIOR TO REPROCESSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629903 ↗