Cidex™ 20398Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705037000135), received between Aug 30, 2018 and Nov 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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. How this data works · Data updated Oct 13, 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, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED AN EVENT OF EXPIRED CIDEX OPA CONCENTRATE BEING USED TO REPROCESS INSTRUMENTS, WHICH WERE RELEASED FOR USE ON PATIENTS. THE EXPIRED DISINFECTANT WAS IN USE FOR APPROXIMATELY FOUR WEEKS BEFORE THE ERROR WAS DISCOVERED, AND THE AFFECTED INSTRUMENTS WERE RELEASED AND USED ON 13 PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THE EXPIRED CIDEX OPA CONCENTRATE WAS USED IN TWO EVOTECH¿ ECRS AT THIS FACILITY. THIS REPORT IS FOR EVOTECH #2 AND PATIENT #2, REFER TO THE MANUFACTURER REPORT NUMBER 2084725-2021-00434 FOR THE REPORT ON EVOTECH #1 AND PATIENT #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861933 ↗
• MalfunctionNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED AN EVENT OF EXPIRED CIDEX OPA CONCENTRATE BEING USED TO REPROCESS INSTRUMENTS, WHICH WERE RELEASED FOR USE ON PATIENTS. THE EXPIRED DISINFECTANT WAS IN USE FOR APPROXIMATELY FOUR WEEKS BEFORE THE ERROR WAS DISCOVERED, AND THE AFFECTED INSTRUMENTS WERE RELEASED AND USED ON 13 PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THE EXPIRED CIDEX OPA CONCENTRATE WAS USED IN TWO EVOTECH¿ ECRS AT THIS FACILITY. THIS REPORT IS FOR EVOTECH¿ #1 AND PATIENT #1, REFER TO THE MANUFACTURING REPORT NUMBER 2084725-2021-00435 FOR THE REPORT ON EVOTECH¿ #2 AND PATIENT #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861932 ↗
• MalfunctionAug 30, 2018Failure to Disinfect; Failure to Disinfect

  IT WAS REPORTED BY AN ADVANCED STERILIZATION PRODUCTS (ASP) FIELD SERVICE ENGINEER (FSE) THAT WHILE ONSITE PERFORMING PLANNED MAINTENANCE ON THE CUSTOMER¿S EVOTECH® ECR, THE CUSTOMER WAS USING EXPIRED CIDEX® OPA SOLUTION IN THEIR EVOTECH® ECR. THE CUSTOMER ENTERED THE EXPIRATION DATE OF ENTERED SEPTEMBER 2018 INTO THE EVOTECH® ECR INSTEAD OF THE ACTUAL EXPIRATION DATE OF APRIL 2018. THE FSE WENT TO REPLACE THE CIDEX® OPA SOLUTION AND DISCOVERED THAT THE SOLUTION ON THE SHELF WAS ALSO EXPIRED. IT WAS NOTED, HOWEVER, THE SOLUTION WAS MEETING THE MINIMUM EFFECTIVE CONCENTRATION (MEC). A CONFERENCE CALL WAS INITIATED BY ASP AND THE FACILITY TO NOTIFY THEM OF THE ERROR. ALL ENDOSCOPES THAT WERE REPROCESSED DURING THIS TIME PERIOD WERE PULLED FROM THE SHELVES AND IT WAS DETERMINED BY THE FACILITY THAT SCOPES WERE USED ON 6 PATIENTS. THERE HAS BEEN NO REPORT OF ANY INFECTION OR INJURIES REPORTED TO DATE. HOWEVER, THE FACILITY IS TRACKING THESE PATIENTS. ASP WILL CONTINUE TO FOLLOW-UP AND IF NEW INFORMATION IS RECEIVED REGARDING A CHANGE IN THE PATIENT¿S STATUS, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. ASP HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT FOLLOW THE IFU WHEN P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833925 ↗