CIDEX™ 20390Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705037000074), received between May 24, 2018 and Jan 5, 2024 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K030004); they may or may not involve this specific model.

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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED AN EVENT WHERE AN EXPIRED NON-ASP TEST STRIP, MANUFACTURED BY MCKESSON INDICATOR STRIP, WAS USED TO VERIFY THE MINIMUM EFFECTIVE CONCENTRATION (MEC) FOR THE CIDEX¿ OPA SOLUTION. IT WAS REPORTED THAT A VAGINAL PROBE WAS PROCESSED IN THE AFFECTED SOLUTION AND WAS RELEASED AND USED ON A PATIENT DURING SURGERY. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO THE PATIENT ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ASP HAS DECIDED TO REPORT ALL INCIDENTS WHERE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED AND THE DEVICE WAS RELEASED AND USED ON A PATIENT WITHOUT REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460513 ↗
• MalfunctionJun 15, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF MULTIPLE USE ERRORS IDENTIFIED AT THEIR FACILITY INVOLVING INSTRUMENT REPROCESSING WITH CIDEX® OPA SOLUTION. THE CUSTOMER STATED THAT APPROXIMATELY SINCE (B)(6) 2022, THE FACILITY HAD BEEN REPROCESSING WITH CIDEX® OPA SOLUTION WITHOUT MONITORING THE TEMPERATURE OR USING THE TEST STRIPS TO CHECK THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE FACILITY REPLACES THE CIDEX® OPA SOLUTION EVERY 30 DAYS INSTEAD OF THE MAXIMUM 14 DAYS OF REUSE AS PER THE CIDEX® OPA INSTRUCTIONS FOR USE (IFU). LASTLY, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S). HOWEVER; THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. ALTHOUGH NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY RELATED TO THESE STATED USE ERRORS, AS A MATTER OF POLICY, ASP HAS DECIDED TO REPORT ALL THESE INCIDENTS WHEN THE INVOLVED DEVICES HAVE BEEN RELEASED FOR USE ON PATIENT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698979 ↗
• MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF MEDICAL INSTRUMENT CORROSION, AND THAT A HEALTHCARE WORKER (HCW) EXPERIENCED BLUE SKIN DISCOLORATION ON THE HANDS WHEN PROCESSING WITH CIDEX® OPA SOLUTION. THE BLUE SKIN DISCOLORATION LASTED FOR ONE DAY AND RESOLVED WITH SEVERAL HAND WASHINGS, AND THE CUSTOMER REPORTED THAT ¿NO ADVERSE SKIN REACTIONS¿ OCCURRED, ONLY ¿TEMPORARY STAINING¿. IN ADDITION, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S); HOWEVER, THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. THE HCW PROVIDED ADDITIONAL EVENT INFORMATION THAT STATED THE MEDICAL INSTRUMENTS/TOOLS WERE FIRST OBSERVED TO BE ¿DAMAGED¿ ON (B)(6) 2022. THE HCW REPORTED THAT THE MEDICAL INSTRUMENTS WERE IMMERSED IN CIDEX® OPA SOLUTION FOR TWO TO FIVE MINUTES, THEN THE INSTRUMENTS WERE PLACED ON PAPER TO AIR DRY. THE HCW ALSO REPORTED THAT NO TEST STRIPS WERE USED TO MEASURE THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE SOLUTION TEMPERATURE WAS NOT MONITORED. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, MULTIPLE USE ERRORS HAVE BEEN IDENTIFIED PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU). THE REPORTED SKIN REACTION HAS

  Patient problems: Skin Discoloration

  MAUDE report 14686374 ↗
• MalfunctionJun 14, 2022Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF MEDICAL INSTRUMENT CORROSION, AND THAT A HEALTHCARE WORKER (HCW) EXPERIENCED BLUE SKIN DISCOLORATION ON THE HANDS WHEN PROCESSING WITH CIDEX® OPA SOLUTION. THE BLUE SKIN DISCOLORATION RESOLVED IN THREE DAYS WITH HAND WASHING AND THE USE OF ALCOHOL, AND THE CUSTOMER REPORTED THAT ¿NO ADVERSE SKIN REACTIONS¿ OCCURRED, ONLY ¿TEMPORARY STAINING¿. IN ADDITION, THE CUSTOMER REPORTED INSTRUMENTS WERE RELEASED AND USED ON PATIENT(S); HOWEVER, THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENTS ASSOCIATED WITH THIS EVENT. THE HCW PROVIDED ADDITIONAL EVENT INFORMATION THAT STATED THE MEDICAL INSTRUMENTS/TOOLS WERE FIRST OBSERVED TO BE ¿DAMAGED¿ IN (B)(6) 2021, APPROXIMATELY WHEN THE FACILITY BEGAN USING CIDEX® OPA. THE HCW REPORTED THAT THE MEDICAL INSTRUMENTS WERE IMMERSED IN CIDEX® OPA SOLUTION FOR FIVE TO EIGHT MINUTES, THEN THE INSTRUMENTS WERE PLACED ON A PAPER TOWEL TO DRY. THE HCW INDICATED THAT NO TEST STRIPS WERE USED TO MEASURE THE MINIMUM EFFECTIVE CONCENTRATION (MEC), AND THE SOLUTION TEMPERATURE WAS NOT MONITORED. THE ADDITIONAL INFORMATION ALSO INDICATED THAT TOOLS/INSTRUMENTS WERE STORED OR KEPT IN CIDEX® OPA SOLUTION FOR 12 HOURS; HOWE

  Patient problems: Skin Discoloration

  MAUDE report 14686117 ↗
• MalfunctionDec 20, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF CIDEX® OPA SOLUTION BEING USED AT 17.2 DEGREES CELSIUS TO REPROCESS A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEEC) PROBE, AND THE PROBE WAS RELEASED AND USED ON A PATIENT. AS PER THE CIDEX® OPA INSTRUCTIONS FOR USE (IFU), THE MINIMUM TEMPERATURE FOR REPROCESSING IS 20 DEGREES CELSIUS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL INCIDENTS OF CIDEX® OPA SOLUTION BEING USED UNDER THE MINIMUM REPROCESSING TEMPERATURE AND THE INSTRUMENT WAS RELEASED AND USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046511 ↗
• MalfunctionDec 6, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED THAT THEIR FACILITY DID NOT FOLLOW THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) FOR INSTRUMENT RINSING, AND THE INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THE FACILITY CONFIRMED THERE WERE NO PATIENT SYMPTOMS AND NO INJURIES REPORTED. PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU), A MINIMUM OF THREE ONE-MINUTE RINSES ARE REQUIRED USING LARGE VOLUMES OF FRESH WATER. IT WAS REPORTED THAT THERE WAS HUMAN CONTACT WITH A MEDICAL DEVICE THAT WAS NOT RINSED PER CIDEX® OPA SOLUTION IFU; THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936937 ↗
• MalfunctionNov 30, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF TWO PATIENTS EXPERIENCED ADVERSE URINARY REACTIONS POST CYSTOSCOPY PROCEDURES WITH INSTRUMENTS THAT WERE REPROCESSED WITH CIDEX OPA SOLUTION. ONE OF THE TWO PATIENTS REPORTED BURNING SENSATION RIGHT AFTER THE PROCEDURE; HOWEVER, IT IS UNCLEAR WHICH OF THE TWO PATIENTS EXPERIENCED THE IMMEDIATE REACTION. THE CUSTOMER STATED THAT THE INCIDENT IS NOT CONSIDERED A SERIOUS INJURY AND REPORTED THAT THE PATIENTS ARE "FINE". THIS REPORT IS FOR A PATIENT WITH BLADDER CANCER WHO UNDERWENT A CYSTOSCOPY WITH A WOLF FLEXIBLE CYSTOSCOPE. THE PATIENT RECEIVED A LOCAL ANESTHETIC (5% LIDOCAINE JELLY) INJECTED INTO THE URETHRA. THE PATIENT EXPERIENCED BURNING URETHRA WHILE URINATING POST PROCEDURE. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ORAL ANTIBIOTICS; HOWEVER, IT IS NOT KNOWN IF THESE ANTIBIOTICS ARE GIVEN TO ALL CYSTOSCOPY PATIENTS. ADDITIONALLY, IT WAS RECOMMENDED TO TAKE AZO, WHICH IS AN ORAL OVER-THE-COUNTER (OTC) MEDICATION, TO RELIEVE THE BURNING SENSATION. IT IS NOT KNOWN IF THE PATIENT TOOK THIS OTC MEDICATION OR THE DURATION OF TREATMENT. THE CUSTOMER PROVIDED THAT THE INSTRUMENTS REPROCESSING PROCEDURE INCLUDED IMMERSION IN A DILUTED NON-ASP DETERGENT (P

  Patient problems: Burning Sensation

  MAUDE report 12903020 ↗
• MalfunctionNov 30, 2021Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED AN EVENT OF TWO PATIENTS EXPERIENCED ADVERSE URINARY REACTIONS POST CYSTOSCOPY PROCEDURES WITH INSTRUMENTS THAT WERE REPROCESSED WITH CIDEX OPA SOLUTION. ONE OF THE TWO PATIENTS REPORTED BURNING SENSATION RIGHT AFTER THE PROCEDURE; HOWEVER, IT IS UNCLEAR WHICH OF THE TWO PATIENTS EXPERIENCED THE IMMEDIATE REACTION. THE CUSTOMER STATED THAT THE INCIDENT IS NOT CONSIDERED A SERIOUS INJURY AND REPORTED THAT THE PATIENTS ARE "FINE". THE PATIENT RECEIVED A LOCAL ANESTHETIC (5% LIDOCAINE JELLY) INJECTED INTO THE URETHRA PRIOR TO THE CYSTOSCOPY WITH A WOLF FLEXIBLE CYSTOSCOPE. THE PATIENT EXPERIENCED BURNING URETHRA WHILE URINATING POST PROCEDURE. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ORAL ANTIBIOTICS; HOWEVER, IT IS NOT KNOWN IF THESE ANTIBIOTICS ARE GIVEN TO ALL CYSTOSCOPY PATIENTS. ADDITIONALLY, IT WAS RECOMMENDED TO TAKE AZO, WHICH IS AN ORAL OVER-THE-COUNTER (OTC) MEDICATION, TO RELIEVE THE BURNING SENSATION. IT IS NOT KNOWN IF THE PATIENT TOOK THIS OTC MEDICATION OR THE DURATION OF TREATMENT. THE CUSTOMER PROVIDED THAT THE INSTRUMENTS REPROCESSING PROCEDURE INCLUDED IMMERSION IN A DILUTED NON-ASP DETERGENT (PROLYSTICA), THEN IMMERSION IN CIDEX® OPA SOLUTION, AN

  Patient problems: Burning Sensation

  MAUDE report 12903017 ↗
• MalfunctionNov 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED THAT HIS FACILITY IS NOT FOLLOWING THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) FOR MINIMUM TEMPERATURE AND DEVICE RINSING, AND HE HAD CONTACTED ADVANCED STERILIZATION PRODUCTS (ASP) FOR CONFIRMATION OF THE CORRECT PROCESS. HE REPORTED THAT AS PER THE FACILITY¿S INSTRUCTIONS, CIDEX® OPA SOLUTION WAS USED TO REPROCESS INSTRUMENTS WHEN IT WAS BELOW MINIMUM TEMPERATURE OF 68 DEGREES FAHRENHEIT, AND THE FACILITY ALSO REUSED THE RINSE WATER. ASP CONFIRMED AND ADVISED THE CUSTOMER THAT THE MINIMUM TEMPERATURE FOR CIDEX® OPA SOLUTION MANUAL PROCESSING IS 68 DEGREES FAHRENHEIT, AND THE RINSE WATER SHOULD BE DISCARDED AFTER EACH RINSE. THE CUSTOMER CONFIRMED THAT THE INCORRECTLY PROCESSED INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF CIDEX® OPA SOLUTION BEING USED BELOW THE MINIMUM TEMPERATURE, WITH THE AFFECTED INSTRUMENTS RELEASED AND USED ON PATIENTS. IT WAS ALSO REPORTED THAT THERE WAS HUMAN CONTACT WITH A MEDICAL DEVICE THAT WAS NOT RINSED PER CIDEX® OPA SOLUTION IFU; THEREFORE, THIS EVENT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865225 ↗
• MalfunctionJul 7, 2021Failure to Disinfect; Failure to Disinfect

  A CUSTOMER REPORTED USING CIDEX® OPA SOLUTION BELOW THE MINIMUM TEMPERATURE REQUIREMENT OF 68° FAHRENHEIT FOR MANUAL REPROCESSING OF THEIR INSTRUMENTS. THE CUSTOMER STATED THE SOLUTION WAS USED AT 65° FAHRENHEIT AND THE REPROCESSED INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THE FACILITY CONFIRMED THERE WERE NO PATIENT SYMPTOMS AND NO SERIOUS INJURIES REPORTED. PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU), HIGH LEVEL DISINFECTION IS ACHIEVED BY THE DISINFECTANT WHEN USED AT A MINIMUM OF 20° CELSIUS (68° FAHRENHEIT) WITH AN IMMERSION TIME OF AT LEAST 12 MINUTES. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT FOLLOW THE IFU WHEN PROCESSING THEIR SCOPES IN CIDEX® OPA SOLUTION SINCE ASP IS NOT ABLE TO GUARANTEE IT HAS BEEN HIGH LEVEL DISINFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132091 ↗
• MalfunctionApr 6, 2021Failure to Disinfect; Failure to Disinfect

  A CUSTOMER REPORTED USING CIDEX® OPA SOLUTION BELOW THE MINIMUM TEMPERATURE REQUIREMENT OF 68° FAHRENHEIT FOR MANUAL REPROCESSING OF THEIR INSTRUMENTS. DURING A QUALITY CHECK OF THEIR CIDEX® OPA RECORDS, THE CUSTOMER DISCOVERED THE SOLUTION WAS USED TWICE AT TEMPERATURES BELOW THE REQUIREMENT AS STATED IN THE INSTRUCTIONS FOR USE (IFU), AND THE REPROCESSED INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THE FACILITY CONFIRMED THERE WERE NO PATIENT SYMPTOMS AND NO SERIOUS INJURIES REPORTED. PER THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU), HIGH LEVEL DISINFECTION IS ACHIEVED BY THE DISINFECTANT WHEN USED AT A MINIMUM OF 20° CELSIUS (68° FAHRENHEIT) WITH AN IMMERSION TIME OF AT LEAST 12 MINUTES. THE CUSTOMER CONFIRMED THE IMMERSION TIME OF 12 MINUTES WAS MET AND STATED THE INVOLVED SOLUTION WAS TESTED AND MET THE MINIMUM EFFECTIVE CONCENTRATION (MEC) PRIOR TO USE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT FOLLOW THE IFU WHEN PROCESSING THEIR SCOPES IN CIDEX® OPA SOLUTION SINCE ASP IS NOT ABLE TO GUARANTEE IT HAS BEEN HIGH LEVEL DISINFECTED.

  Patient problems: Insufficient Information

  MAUDE report 11620170 ↗
• MalfunctionFeb 19, 2021Failure to Disinfect

  A CUSTOMER REPORTED THEY WERE DILUTING THEIR CIDEX® OPA SOLUTION TO HIGH-LEVEL DISINFECT A ¿SELF-MOUTH MASK,¿ AND THE MASK WAS RELEASED AND USED ON A STUDENT. UPON FOLLOW-UP WITH THE CUSTOMER, IT WAS DISCOVERED THE CUSTOMER WAS NOT FOLLOWING THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) AND DID NOT MONITOR THE TEMPERATURE OF THE SOLUTION PRIOR TO USE OR TEST THE SOLUTION FOR THE MINIMUM EFFECTIVE CONCENTRATION (MEC). THE INSTRUCTIONS FOR USE (IFU) STATES THE CONCENTRATION OF THE SOLUTION MUST BE VERIFIED BY THE CIDEX® OPA SOLUTION TEST STRIP PRIOR TO EACH USE TO DETERMINE THAT THE CONCENTRATION OF ORTHO-PHTHALALDEHYDE IS ABOVE THE MEC OF 0.3%. IN ADDITION, CIDEX® OPA SOLUTION SHOULD BE AT A MINIMUM OF 68 DEGREES F. THERE WAS NO REPORT OF INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT TEST THE CIDEX® OPA SOLUTION WITH CIDEX® OPA TEST STRIPS FOR THE MINIMUM EFFECTIVE CONCENTRATION (MEC) PRIOR TO USE AND DOES NOT MONITOR THE TEMPERATURE OF THE SOLUTION SINCE ASP IS NOT ABLE TO GUARANTEE IT HAS BEEN HIGH LEVEL DISINFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11349007 ↗
• MalfunctionNov 20, 2020Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED THEY DO NOT MONITOR THE TEMPERATURE OF THEIR CIDEX® OPA SOLUTION PRIOR TO USE, AND THE CIDEX® OPA SOLUTION WAS USED FOR MANUAL REPROCESSING ON CPAP INSTRUMENTS THAT WERE RELEASED AND USED ON PATIENTS. THERE IS NO REPORT OF ANY PATIENT INJURIES OR INFECTIONS. THE INSTRUCTIONS FOR USE (IFU) STATES THE SOLUTION MUST BE AT A MINIMUM 68 DEGREES F FOR HIGH LEVEL DISINFECTION AND SHOULD BE MEASURED PRIOR TO USE. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT FOLLOW THE IFU WHEN PROCESSING THEIR INSTRUMENTS IN CIDEX® OPA SOLUTION SINCE ASP IS NOT ABLE TO GUARANTEE IT HAS BEEN HIGH LEVEL DISINFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10880807 ↗
• MalfunctionMar 10, 2020Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem

  A CUSTOMER REPORTED USING CIDEX® OPA SOLUTION PAST THE 14-DAY REUSE DATE AND THE INSTRUMENTS WERE RELEASED AND USED ON PATIENTS. THE CUSTOMER STATED THE SOLUTION WAS TESTED PRIOR TO USE AND MET THE MINIMUM EFFECTIVE CONCENTRATION (MEC). THERE WERE NO REPORTS OF ANY INJURY, HARM OR INFECTIONS REPORTED. PER THE INSTRUCTIONS FOR USE (IFU), CIDEX® OPA SOLUTION MAY BE REUSED FOR UP TO A MAXIMUM OF 14 DAYS PROVIDED THE REQUIRED CONDITIONS OF ORTHO-PHTHALALDEHYDE CONCENTRATION AND TEMPERATURE EXIST BASED UPON MONITORING DESCRIBED IN THE DIRECTIONS FOR USE. DO NOT RELY SOLELY ON DAYS IN USE. CONCENTRATION OF THIS PRODUCT DURING ITS REUSE LIFE MUST BE VERIFIED BY THE CIDEX® OPA SOLUTION TEST STRIP PRIOR TO EACH USE TO DETERMINE THAT THE CONCENTRATION OF ORTHO-PHTHALALDEHYDE IS ABOVE THE MEC OF 0.3%. THE PRODUCT MUST BE DISCARDED AFTER 14 DAYS, EVEN IF THE CIDEX® OPA SOLUTION TEST STRIP INDICATES A CONCENTRATION ABOVE THE MEC. ALTHOUGH THERE IS NO PATIENT HARM OR INJURY REPORTED, ADVANCED STERILIZATION PRODUCTS HAS DECIDED TO REPORT CASES WHEN THE CUSTOMER USES EXPIRED PRODUCT AND RELEASES THE INSTRUMENTS FOR USE SINCE HIGH-LEVEL DISINFECTION CANNOT BE ASSURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812390 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673874 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673869 ↗
• MalfunctionFeb 5, 2020Defective Device

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673868 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673866 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673859 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673856 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673798 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673785 ↗
• MalfunctionFeb 5, 2020Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673782 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673781 ↗
• MalfunctionFeb 5, 2020Problem with Sterilization; Improper or Incorrect Procedure or Method

  A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX® OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ¿FINE.¿ THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX® OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A M

  Patient problems: Burning Sensation; Skin Discoloration

  MAUDE report 9673760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030004. One submission often covers many models, so check the product and lot details in each record.

• Z-2774-2015 · Aug 10, 2015 · Terminated
  CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
• Z-2276-2012 · Jun 1, 2012 · Terminated
  CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disi